Who is the manufacturer of ACUSON P600 Diagnostic Ultrasound System?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for ACUSON P600 Diagnostic Ultrasound System (K180039).

What is the FDA product code for ACUSON P600 Diagnostic Ultrasound System?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ACUSON P600 Diagnostic Ultrasound System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ACUSON P600 Diagnostic Ultrasound System?

ACUSON X700 (K141846); ACUSON S2000 (K163635); ACUSON P500 (K163396); ACUSON SC2000 (K170315).

Who can help prepare an FDA 510(k) submission like ACUSON P600 Diagnostic Ultrasound System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACUSON P600 Diagnostic Ultrasound System

K180039 · Siemens Medical Solutions USA, Inc. · IYN · Feb 1, 2018 · Radiology

Device Facts

Record ID	K180039
Device Name	ACUSON P600 Diagnostic Ultrasound System
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	IYN · Radiology
Decision Date	Feb 1, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gynecological, Intraoperative, and Urological applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures analysis packages that provide information used by a physician for clinical diagnosis purposes. Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

Device Story

Multi-purpose mobile diagnostic ultrasound system; acquires harmonic ultrasound echo data; displays in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Color M, Doppler Tissue, Amplitude Doppler, 3D/4D imaging on flat panel display. Operated by clinicians in clinical settings. Provides anatomical measurements and analysis packages (e.g., Arterial Health Package for Intima Media Thickness) to assist physician diagnosis and patient communication. System transmits ultrasonic energy into patients; performs post-processing of received echoes to generate visual representation of anatomy and fluid flow. Benefits include non-invasive diagnostic imaging aid for various clinical applications.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing per recognized standards (e.g., IEC 60601 series, ISO 10993-1).

Technological Characteristics

Mobile, software-controlled diagnostic ultrasound system. Supports multiple imaging modes (2D, M, PW/CW Doppler, Color/Power Doppler). Connectivity includes DICOM 3.0. Complies with ANSI/AAMI ES 60601-1, AIUM/NEMA UD-2/UD-3, IEC 62359, IEC 60601-2-18, IEC 60601-2-37, ISO 10993-1, and ISO 14971.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in vascular, abdominal, neonatal, echocardiographical, pediatric, small parts, musculoskeletal, obstetrical, gynecological, intraoperative, and urological applications. Includes specific procedures for IVF, CVS, and PUBS.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

ACUSON X700 (K141846)
ACUSON S2000 (K163635)
ACUSON P500 (K163396)
ACUSON SC2000 (K170315)

Related Devices

K123001 — ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Oct 26, 2012
K130619 — ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Mar 21, 2013
K121699 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jun 22, 2012
K132804 — ACUSON S1000 / S2000 / S3000 · Siemens Medical Solutions USA, Inc. Ultrasound Gro · Oct 24, 2013
K173981 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. Ultrasound Group · Feb 2, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The text reads U.S. FOOD & DRUG ADMINISTRATION. Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313 February 5, 2018 Re: K180039 Trade/Device Name: ACUSON P600 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 3, 2018 Received: January 5, 2018 Dear Mark Job: This letter corrects our substantially equivalent letter of February 1, 2018. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@)da.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jeff Balyer for Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K180039 #### Device Name ACUSON P600 Diagnostic Ultrasound System #### Indications for Use (Describe) The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gynecological, Intraoperative, and Urological applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures analysis packages that provide information used by a physician for clinical diagnosis purposes. Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular svstem. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine." Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------| |----------------------------------------------------------------------------------------------------------|-----------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 510(k) Number (if known): #### ACUSON P600™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | N | N | N | | N | N | BCDM | | | Obstetrics (Note 2) | N | N | N | | N | N | BCDM | | | Gynecology (Note 3) | N | N | N | | N | N | BCDM | | | Small Parts (Note 4) | N | N | N | | N | N | BCDM | | | Pediatric (Note 5) | N | N | N | N | N | N | BCDM | | | Neonatal (Note 6) | N | N | N | N | N | N | BCDM | | | Vascular (Note 7) | N | N | N | N | N | N | BCDM | | | Urology (Note 8) | N | N | N | | N | N | BCDM | | | Echocardiography (Note 9) | N | N | N | N | N | N | BCDM | | | Musculoskeletal (Note 10) | N | N | N | | N | N | BCDM | | | Intraoperative (Note 11) | N | N | N | | N | N | BCDM | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {4}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 5C1 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: Clinical Mode of Operation Application 2D Color Power Combined Other M PWD CWD (B) Doppler Doppler (Specify) (Specify) | Ophthalmic | | | | | | | |------------------------------|---|---|---|---|---|------| | Abdominal (Note 1) | N | N | N | N | N | BCDM | | Obstetrics (Note 2) | N | N | N | N | N | BCDM | | Gynecology (Note 3) | N | N | N | N | N | BCDM | | Small Parts (Note 4) | | | | | | | | Pediatric (Note 5) | | | | | | | | Neonatal (Note 6) | | | | | | | | Vascular (Note 7) | N | N | N | N | N | BCDM | | Urology (Note 8) | N | N | N | N | N | BCDM | | Echocardiography (Note 9) | | | | | | | | Musculoskeletal (Note 10) | N | N | N | N | N | BCDM | | Intraoperative (Note 11) | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {5}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 5P1 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | N | N | N | | N | N | BCDM | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | N | N | N | | N | N | BCDM | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | N | N | N | | N | N | BCDM | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {6}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 11L4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | N | N | N | N | N | N | BCDM | | | Obstetrics (Note 2) | N | N | N | N | N | N | BCDM | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | N | N | N | N | N | N | BCDM | | | Pediatric (Note 5) | N | N | N | N | N | N | BCDM | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | N | N | N | N | N | N | BCDM | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | N | N | N | N | N | N | BCDM | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {7}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 12L3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | N | N | N | | N | N | BCDM | | | Obstetrics (Note 2) | N | N | N | | N | N | BCDM | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | N | N | N | | N | N | BCDM | | | Pediatric (Note 5) | N | N | N | | N | N | BCDM | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | N | N | N | | N | N | BCDM | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | N | N | N | | N | N | BCDM | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {8}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 16L4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | N | N | N | | N | N | BCDM | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | N | N | N | | N | N | BCDM | | | Pediatric (Note 5) | N | N | N | | N | N | BCDM | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | N | N | N | | N | N | BCDM | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | N | N | N | | N | N | BCDM | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {9}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 18H5 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | N | N | N | | N | N | BCDM | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | N | N | N | | N | N | BCDM | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | N | N | N | | N | N | BCDM | | | Intraoperative (Note 11) | N | N | N | | N | N | BCDM | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {10}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 9VE3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | N | N | N | | N | N | BCDM | | | Gynecology (Note 3) | N | N | N | | N | N | BCDM | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) {11}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 8VC3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | N | N | N | N | N | N | BCDM | | | Obstetrics (Note 2) | N | N | N | N | N | N | BCDM | | | Gynecology (Note 3) | N | N | N | N | N | N | BCDM | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {12}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 10MC3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | N | N | N | | N | N | BCDM | | | Gynecology (Note 3) | N | N | N | | N | N | BCDM | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | N | N | N | | N | N | BCDM | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {13}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 9MC3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | N | N | N | | N | N | BCDM | | | Gynecology (Note 3) | N | N | N | | N | N | BCDM | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | N | N | N | | N | N | BCDM | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {14}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 10V4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | P | P | P | P | P | P | BCDM | | | Neonatal (Note 6) | P | P | P | P | P | P | BCDM | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | P | P | P | P | P | P | BCDM | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared (K163635) | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {15}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 8V4 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | N | N | N | N | N | N | BCDM | | | Neonatal (Note 6) | N | N | N | N | N | N | BCDM | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | N | N | N | N | N | N | BCDM | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {16}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 7C2 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | N | N | N | N | N | N | BCDM | | | Obstetrics (Note 2) | N | N | N | N | N | N | BCDM | | | Gynecology (Note 3) | N | N | N | N | N | N | BCDM | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | N | N | N | N | N | N | BCDM | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | N | N | N | N | N | N | BCDM | | | Echocardiography (Note 9) | | | | | | | | | | Musculoskeletal (Note 10) | N | N | N | N | N | N | BCDM | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {17}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: 11M3 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | N | N | N | | N | N | BCDM | | | Neonatal (Note 6) | N | N | N | | N | N | BCDM | | | Vascular (Note 7) | N | N | N | | N | N | BCDM | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | N | N | N | | N | N | BCDM | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {18}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: CW2 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | | | | | | | | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | P | | | | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared (K163635) | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {19}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: CW5 for ACUSON P600™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | |------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------| | | 2D (B) | M | PWD | CWD | Color Doppler | Power Doppler | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | Abdominal (Note 1) | | | | | | | | | | Obstetrics (Note 2) | | | | | | | | | | Gynecology (Note 3) | | | | | | | | | | Small Parts (Note 4) | | | | | | | | | | Pediatric (Note 5) | | | | | | | | | | Neonatal (Note 6) | | | | | | | | | | Vascular (Note 7) | | | | P | | | | | | Urology (Note 8) | | | | | | | | | | Echocardiography (Note 9) | | | | P | | | | | | Musculoskeletal (Note 10) | | | | | | | | | | Intraoperative (Note 11) | | | | | | | | | N = new indication; P = previously cleared (K163635) | Note 1 | Abdominal (Abdominal, Renal, Bowel, Focused Assessment with Sonography for Trauma, Lung) | |---------|--------------------------------------------------------------------------------------------------| | Note 2 | Obstetrics (Obstetrics, Early Obstetrics, Fetal Echocardiography, Advanced Obstetrics) | | Note 3 | Gynecology (Gynecology, Pelvic Floor) | | Note 4 | Small Parts (Breast, Testicles, Penile, Thyroid) | | Note 5 | Pediatric (Pediatric Hip Joint, Pediatric Abdomen) | | Note 6 | Neonatal (Neonatal Head) | | Note 7 | Vascular (Carotid, Peripheral Venous, Peripheral Arterials, Transcranial Doppler) | | Note 8 | Urology (Pelvis, Prostate) | | Note 9 | Echocardiography (Adult Echocardiography, Pediatric Echocardiography, Neonatal Echocardiography) | | Note 10 | Musculoskeletal (Spine, Musculoskeletal, Digital, Nerve) | | Note 11 | Intraoperative (Intraoperative Abdomen, Intraoperative Vascular) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) - {20}------------------------------------------------ #### 510(k) Summary | Date: | August 31, 2017 | | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------|--------| | Submitter: | Siemens Medical Solutions USA, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043 | | | | Manufacturing Facility: | Siemens Healthcare Ltd. 2nd -3rd floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea | | | | Contact Person: | Sulgue Choi Tel: (425) 281-9898 | | | | Device Name: | ACUSON P600 Diagnostic Ultrasound System | | | | Common Name: | Diagnostic Ultrasound System with Accessories | | | | Classification: | Regulatory Class: II Review Category: Tier II Classification Panel: Radiology | | | | | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | #### A. Legally Marketed Predicate Devices The ACUSON P600 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products, the ACUSON X700 (K141846), ACUSON S2000 (K163635), ACUSON P500 (K163396) and ACUSON SC2000 (K170315). {21}------------------------------------------------ #### B. Device Description The ACUSON P600 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display. #### C. Intended Use The ACUSON P600 ultrasound imaging system is intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical. Gynecological. Intraoperative, and Urological applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and analysis packages that provide information that is used by a physician for clinical diagnosis purposes. Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous u…