Who is the manufacturer of Acuson SC2000 Diagnostic Ultrasound System?

Siemens Medi Cal Solutions, Inc. filed the 510(k) submission for Acuson SC2000 Diagnostic Ultrasound System (K171766).

What is the FDA product code for Acuson SC2000 Diagnostic Ultrasound System?

IYO. It is classified under 21 CFR 892.1560 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Acuson SC2000 Diagnostic Ultrasound System?

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

What are the predicate devices for Acuson SC2000 Diagnostic Ultrasound System?

ACUSON SC2000 Diagnostic Ultrasound System (K170315).

Who can help prepare an FDA 510(k) submission like Acuson SC2000 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 SC2000 Diagnostic Ultrasound System

K171766 · Siemens Medi Cal Solutions, Inc. · IYO · Jul 12, 2017 · Radiology

Device Facts

Record ID	K171766
Device Name	Acuson SC2000 Diagnostic Ultrasound System
Applicant	Siemens Medi Cal Solutions, Inc.
Product Code	IYO · Radiology
Decision Date	Jul 12, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1560
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis The system transmits ultrasound energy into adult, pediativ, neonatal, and fetal cardiac patients creating 2D (B). 3D. M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system also supports catheters which are intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. Intraoperative Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures. Transcranial Imaging Applications The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires primary/secondary harmonic ultrasound echo data. Inputs: ultrasound signals via various transducers (matrix, phased, linear, curved arrays) and optional ECG for synchronization. Transforms inputs into 2D (B), 3D, 4D (real-time 3D), M-Mode, Pulsed/Continuous Wave Doppler, Color Doppler, Amplitude Doppler, and Color Velocity Imaging. Used in clinical settings by physicians for diagnostic imaging and intraoperative guidance. Output: visual display of anatomical structures and blood flow velocity; measurement/calculation packages provide adjunctive data for clinical diagnosis. Benefits: non-invasive visualization of pathology in heart, vessels, brain, and musculoskeletal structures; supports intraluminal visualization via compatible catheters.

Clinical Evidence

No clinical data required; substantial equivalence established via bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal/electromagnetic/mechanical safety testing.

Technological Characteristics

Mobile ultrasound system; supports matrix, phased, linear, and curved array transducers. Modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity, 3D/4D. Connectivity: Wireless, DICOM. Standards: AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62366, IEC 62304, NEMA UD-2, NEMA UD-3, ISO 10993-1.

Indications for Use

Indicated for adult, pediatric, neonatal, and fetal patients requiring ultrasound imaging or fluid flow analysis of cardiac, vascular, abdominal, musculoskeletal, and transcranial structures. Used for diagnostic visualization and guidance during intraoperative procedures. Contraindications not specified.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

ACUSON SC2000 Diagnostic Ultrasound System (K170315)

Related Devices

K113179 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Dec 7, 2011
K170315 — Acuson SC2000 Diagnostic Ultrasound System · Siemens Medi Cal Solutions, Inc. · Apr 4, 2017
K140959 — ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS · Siemens Medical Solutions USA, Inc. · Apr 30, 2014
K040060 — SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS · Siemens Medical Solutions USA, Inc. · Jan 28, 2004
K173957 — ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Feb 1, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 12, 2017 SIEMENS MEDICAL SOLUTIONS INC. 0 Mr. MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW BUFFALO MN 55313 Re: K171766 Trade/Device Name: Acuson SC2000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, IYN, ITX, OBJ Dated: June 2, 2017 Received: June 14, 2017 Dear Mr. Job: 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 (for the indications for use stated in the enclosure) 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D. O'Hara For Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K171766 #### Device Name Acuson SC2000TM Diagnostic Ultrasound System #### Indications for Use (Describe) The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis The system transmits ultrasound energy into adult, pediativ, neonatal, and fetal cardiac patients creating 2D (B). 3D. M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system also supports catheters which are intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. Intraoperative Imaging Applications The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures. Transcranial Imaging Applications The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. {3}------------------------------------------------ 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) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 Drug 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." {4}------------------------------------------------ 510(k) Number (if known): #### Device Name: SC2000 Diagnostic Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: 3D | Other: Real Time 3D | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------|------------------------------| | Ophthalmic | | | | | | | | | | | | | | Fetal | P | P | P | P | P | P | P | | P* | P | | P | | Abdominal | P | P | P | P | P | P | P | | P* | P | P | | | Intraoperative Abdominal | P | P | P | P | P | | | | P* | P | | | | Intraoperative Neurological | | | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P* | P | P | P | | Small Organ (specify) | | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | | Adult Cephalic | P | P | P | P | P | P | P | | P* | P | | | | Cardiac | P | P | P | P | P | P | P | | P* | P | P | P | | Trans-esophageal | P | P | P | P | P | | | | P* | | P | | | Transrectal | | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | | Intra-Luminal | P | P | P | P | P | P | P | | P* | | | P | | Peripheral Vessel | P | P | P | P | P | P | P | P | P* | P | | | | Laparoscopic | | | | | | | | | | | | | | Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P* | P | | | | Musculo-skeletal Superficial | P | P | P | P | P | P | P | | P* | P | | | | Other (Neonatal Cardiac) | P | P | P | P | P | P | P | | P* | P | | | | Other (Intra- Cardiac) | P | P | P | P | P | P | P | | P* | | | P | | Other (Abdominal Vascular) | P | P | P | P | P | P | P | | P* | P | | | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {5}------------------------------------------------ 510(k) Number (if known): CW2 Device Name: Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) | Color Velocity | Combined (Specify) | Other: Harmonic | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|-------------------|-----------------------|--------------------| | | | | | | | | Doppler | Imaging | | Imaging | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | P | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | P | | | | | | | Trans-esophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral Vessel | | | | | P | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N=new indication. Previously Cleared in 510(k) K170315 #### Additional Comments: (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {6}------------------------------------------------ ### 510(k) Number (if known): Device Name: 4Z1c Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: Real Time 3D | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | P | P | P | P | P | | | P* | P | P | | Abdominal | | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | P | P | P | P | P | | | P* | P | P | | Small Organ (specify) ** | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | P | P | P | P | P | | | P* | P | P | | Trans-esophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {7}------------------------------------------------ 510(k) Number (if known): Device Name: 4V1c Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | P | P | P | | P* | P | | Abdominal | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | P | P | P | | P* | P | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | P | P | P | P | P | P | | P* | P | | Cardiac | | P | P | P | P | P | P | | P* | P | | Trans-esophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (Neonatal Cardiac) | | P | P | P | P | P | P | | P* | P | N=new indication. Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {8}------------------------------------------------ ### 510(k) Number (if known): Device Name: V5Ms Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) | Color Velocity | Combined (Specify) | Other: Harmonic | Other: 3D | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|-------------------|-----------------------|--------------------|--------------| | | | | | | | | Doppler | Imaging | | Imaging | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | P | P | P | P | P | | | P* | | P | | Small Organ (specify) | | | | | | | | | | | | | Neonatal | | | | | | | | | | | | | Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | P | P | P | P | P | | | P* | | P | | Trans-esophageal | | P | P | P | P | P | | | P* | | P | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {9}------------------------------------------------ ### 510(k) Number (if known): Device Name: ### ୧୯.IHD Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | P | P | P | | P* | P | | Abdominal | | P | P | P | P | P | P | | P* | P | | Intraoperative Abdominal | | P | P | P | P | P | P | | P* | P | | Intraoperative | | | | | | | | | | | | Pediatric | | P | P | P | P | P | P | | P* | P | | Small Organ (specify) | | P | P | P | P | P | P | | P* | P | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Trans-esophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral Vessel | | P | P | P | P | P | P | | P* | P | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (Abdominal Vascular) | | P | P | P | P | P | P | | P* | P | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {10}------------------------------------------------ ### 510(k) Number (if known): Device Name: #### Z6Ms Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: Real Time 3D | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | P | P | P | P | P | P | | P | P* | P | P | | Trans-esophageal | P | P | P | P | P | P | | P | P* | P | P | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {11}------------------------------------------------ ### 510(k) Number (if known): Device Name: V7M Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: 3D | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | P | P | P | P | P | P | P | | P* | P | P | | Intraoperative Abdominal | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | | | P* | | P | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | P | P | P | P | P | P | | | P* | | P | | Trans-esophageal | P | P | P | P | P | P | | | P* | | P | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {12}------------------------------------------------ ### 510(k) Number (if known): Device Name: 8V3 Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------| | Ophthalmic | | | | | | | | | | | | Fetal | P | P | P | P | P | P | P | | P * | P | | Abdominal | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P * | P | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | P | P | P | P | P | P | P | | P * | P | | Trans-esophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (Neonatal Cardiac) | P | P | P | P | P | P | P | | P * | P | N=new indication. Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {13}------------------------------------------------ 510(k) Number (if known): Device Name: 9L4 Indications for Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Trans-esophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral Vessel | P | P | P | P | | P | P | P | P* | P | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | P | P | P | P | | P | P | P | P* | P | | Musculo-skeletal Superficial | P | P | P | P | | P | P | P | P* | P | | Other (specify) | | | | | | | | | | | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {14}------------------------------------------------ ### 510(k) Number (if known): Device Name: 10V4 Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | P | P | P | | P * | P | | Abdominal | | P | P | P | P | P | P | | P * | P | | Intraoperative Abdominal | | P | P | P | P | P | P | | P * | P | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | P | P | P | | P * | P | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | P | P | P | P | P | P | | P * | P | | Trans-esophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral Vessel | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (Neonatal Cardiac) | | P | P | P | P | P | P | | P * | P | N=new indication. Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {15}------------------------------------------------ 510(k) Number (if known): Device Name: ### AcuNav 8F and 10F Ultrasound Catheter Intended Use: Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: Real Time 3D | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P* | | | | Small Organ (specify) ** | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | P | P | P | P | P | P | P | | P* | | | | Trans-esophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intra-Luminal | P | P | P | P | P | P | P | | P* | | | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (Intra- Cardiac) | P | P | P | P | P | P | P | | P* | | | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {16}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: ACUSON AcuNav™ V 10F Ultrasound Catheter Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: Real Time 3D | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------| | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative Abdominal | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | P | P | P | P | P | P | P | | P* | | P | | Small Organ (specify) ** | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | P | P | P | P | P | P | P | | P* | | P | | Trans-esophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intra-Luminal | P | P | P | P | P | P | P | | P* | | P | | Peripheral Vessel | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (Intra- Cardiac) | P | P | P | P | P | P | P | | P* | | P | N=new indication. P = Previously Cleared in 510(k) K170315 #### Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED) {17}------------------------------------------------ 510(k) Number (if known): Device Name: SoundStar 10F Ultrasound Catheter Intended Use: Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other: Harmonic Imaging | Other: Real Time 3D | | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|------------------------------|--| | Ophthalmic | | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | | Abdominal | | | | |…