Who is the manufacturer of ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM (K061946).

What is the FDA product code for ACUSON X300 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 X300 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What are the predicate devices for ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM?

Antares Diagnostic Ultrasound System (K050034); Sonoline G60 S Diagnostic Ultrasound System (K052894); Sonoline Orchid Diagnostic Ultrasound System (K043016); Acuson CV70 Cardiovascular System (K042044).

Who can help prepare an FDA 510(k) submission like ACUSON X300 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 X300 DIAGNOSTIC ULTRASOUND SYSTEM

K061946 · Siemens Medical Solutions USA, Inc. · IYN · Jul 21, 2006 · Radiology

Device Facts

Record ID	K061946
Device Name	ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	IYN · Radiology
Decision Date	Jul 21, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intracperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Story

The Siemens Acuson X300 is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various transducers. The system processes these inputs to display images in B-Mode, M-Mode, Pulsed (PW) Doppler, Continuous (CW) Doppler, Color Doppler, Amplitude Doppler, 3D, and 4D imaging on a flat panel display. It is operated by clinicians in clinical settings. The system includes analysis packages for measuring anatomical structures and fluid flow, which assist healthcare providers in clinical diagnosis. Benefits include non-invasive visualization of internal structures and hemodynamics to support patient management.

Clinical Evidence

Bench testing only. The device complies with UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 (1998) for acoustic output, and IEC 61157. Biocompatibility is verified per ISO 10993.

Technological Characteristics

Mobile, software-controlled ultrasound system. Supports various phased, convex, and linear array transducers. Imaging modes: B, M, PW/CW Doppler, Color/Amplitude Doppler, 3D/4D. Features include tissue harmonic imaging, panoramic imaging (SieScape), spatial compounding (SieClear), and tissue equalization. Connectivity via standard ultrasound interfaces. Safety standards: IEC 60601-1, IEC 60601-1-2, AIUM/NEMA UD-2.

Indications for Use

Indicated for diagnostic imaging or fluid flow analysis of the human body, including fetal, abdominal, intraoperative, pediatric, small organ (breast, testes, thyroid, penis, prostate), neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, intravascular, peripheral vessel, and musculoskeletal applications. Prescription use only.

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

Antares Diagnostic Ultrasound System (K050034)
Sonoline G60 S Diagnostic Ultrasound System (K052894)
Sonoline Orchid Diagnostic Ultrasound System (K043016)
Acuson CV70 Cardiovascular System (K042044)

Related Devices

K072676 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Dec 18, 2007
K080760 — ACUSON X300 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Apr 25, 2008
K053530 — SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Jan 3, 2006
K090276 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Feb 19, 2009
K121646 — ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. Ultrasound Gro · Jun 22, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ ### Siemens Acuson X300 Diagnostic Ultrasound Syste 510(k) Submission ## 510(K) SUMMARY # JUL 21 2006 ## Siemens Acuson X300 Diagnostic Ultrasound system This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary. #### 1. Submitted By: Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043 Contact Person: Sheila W. Pickering Requiatory Affairs Phone (650) 943 7187 Fax (6500 943 7053 Date Prepared: June 16, 2006 #### 2. Proprietary Names: Siemens Acuson X300™ Diagnostic Ultrasound System Sonoline Premier Plus Diagnostic Ultrasound System Sonavista X 300 Diagnostic Ultrasound System ## Common/ Usual Name: Diagnostic Ultrasound System with Accessories ## Classification Name: 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Diagnostic Ultrasound Transducer FR # 892.1550 FR # 892 1560 FR # 892.1570 Product Code 90-IYN Product Code 90-IYO Product Code 90-1TX #### 3. Predicate Device: - K050034, Antares Diagnostic Ultrasound System . - K052894, Sonoline G60 S Diagnostic Ultrasound System . - K043016, Sonoline Orchid Diagnostic Ultrasound System ● - . K042044, Acuson CV70 Cardiovascular System #### Device Description: 4. The Siemens Acuson X300 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a FPD(Flat Panel Display) display. The Siemens Acuson X300, has been designed to meet the following product safety standards: - 파 UL 60601-1, Safety Requirements for Medical Equipment - 트 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment - AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment {1}------------------------------------------------ - AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound l - 이 93/42/EEC Medical Devices Directive - I Safety and EMC Requirements for Medical Equipment - I EN 60601-1 - . EN 60601-1-1 - I EN 60601-1-2 - . IEC 61157 Declaration of Acoustic Power - l ISO 10993 Biocompatibility #### 5. Intended Uses: The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intracperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. #### 6. Technological Comparison to Predicate Device: The Siemens Acuson X300 is substantially equivalent to the Sonoline Antares (K050034), Sonoline G 60 S (K052894), Sonoline Orchid (K043016) and the Acuson CV70 (K042044), All systems transmit ultrasonic energy into patients, then perform post processing of to-ecoved echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. ## End of 510(k) Summary {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 1 2006 Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K061946 Trade Name: ACUSON X300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 6, 2006 Received: July 10, 2006 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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. This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON C300 Diagnostic Ultrasound System, as described in your premarket notification: {3}------------------------------------------------ | | Transducer Model Number | | |--------|-------------------------|-------------| | P4-2 | BE9-4 | C8-5 | | CH5-2 | CW2 | 8L3 | | VF10-5 | CW5 | 10V4 | | L9-5 | Acu Nav 8F | C7F2 | | EC9-4 | Acu Nav 10F | EV9F4 | | EV9-4 | V5Ms TEE | L13F5 3D/4D | | VF13-5 | 4V1c | | | P8-4 | VF13-5SP | | If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212. Sincerely yours. Nancy Baylor Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {5}------------------------------------------------ 510(k) Number (if known): K061946 ### Device Name: # ACUSON X300 Diagnostic Ultrasound Systems Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Ophthalmic | | | | | | | | | | | | Fetal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Abdominal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Intraoperative (Note 6) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Intraoperative Neurological | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Pediatric | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Small Organ (Note 1) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Neonatal Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Adult Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Cardiac | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Transesophageal | N | N | N | N | N | N | N | BMDC | Note 2,3,7,8,9 | | | Transrectal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Transvaginal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Transurethral | | | | | | | | | | | | Intravascular | N | N | N | N | N | N | N | BMDC | Note 2,3,7,8,9,10 | | | Peripheral vessel | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Musculo-skeletal Superficial | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,9 | | | Other (specify) | N | N | N | N | N | N | N | BMDC | Note 2,3,7,8,9,10 | | N = new indication; P = previously cleared by FDA; E = added under Appendix E For example: breast, testes, thyroid, penis, prostate, etc. Note 1 Note 2 Ensemble tissue harmonic imaging Note 3 3D imaging B&W SieScape panoramic imaging Note 4 Note 5 Power SieScape panoramic imaging For example: abdominal, vascular Note 6 Note 7 Contrast agent imaging SieClear multi-view spatial compounding Note 8 Tissue Equalization Technology Note 9 Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) - Prescription Use (Per 21 CFR 801.109) Diagnostic Ultrasound Indications for Use Form (Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number K061946 {6}------------------------------------------------ 510(k) Number (if known): K061946 Device Name: P4-2 Phased Sector Array Transducer for use with: # ACUSON X300 Diagnostic Ultrasound Systems Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | Combined (Specify) | Other (Specify) | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|-----------------------|--------------------|----------------------|------------------------------| | | A | B | M | PWD | CWD | Color Doppler | | | Amplitude Doppler | Color Velocity Imaging | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,5,6,7,8,9 | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Small Organ (Note 1) | | | | | | | | | | | | Neonatal Cephalic | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Ensemble tissue harmonic imaging Note 2 3D imaging Note 3 Note 4 B&W SieScape panoramic imaging Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent imaging Note 8 SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) P. D. M. PETERSON (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number {7}------------------------------------------------ 510(k) Number (if known): KD61946 CH5-2 Convex Array Transducer for use with: Device Name: ## ACUSON X300 Diagnostic Ultrasound Systems Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | Mode of Operation | | | | | |----------------------------------|---|---|---|-----|-----|-------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Small Organ (Note 1) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | N | N | N | | N | N | | BMDC | Note 2.3.4.5.7.8.9 | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 3D imaging - Note 4 B&W SieScape panoramic imaging - Note 5 Power SieScape panoramic imaging - Note 6 For example: abdominal, vascular Note 7 Contrast agent imaging - Note 8 SieClear multi-view spatial compounding - Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) > -Prescription Use (Per 21 CFR 801.109 (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices ( 510(k) Number N050/1542 {8}------------------------------------------------ 510(k) Number (if known): K061946 Device Name: VF10-5 Linear Array Transducer for use with: # ACUSON X300 Diagnostic Ultrasound Systems Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | Mode of Operation | | | | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Small Organ (Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Musculo-skeletal Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 3D imaging Note 4 B&W SieScape panoramic imaging Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent imaging Note 8 SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) --- (Division Sign-Off) Division of Reproductive, Abdomit and Radiological De 510(k) Number Kola 19 {9}------------------------------------------------ 510(k) Number (if known): K061946 Device Name: L9-5 Linear Array Transducer for use with: # ACUSON X300 Diagnostic Ultrasound Systems Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | BMDC | Note 2.3.4.5.7.8.9 | | Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Small Organ (Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Musculo-skeletal Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E For example: breast, testes, thyroid, penis, prostate, etc. Note 1 Ensemble tissue harmonic imaging Note 2 3D imaqing Note 3 B&W SieScape panoramic imaging Note 4 Power SieScape panoramic imaging Note 5 Note 6 For example: abdominal, vascular Contrast agent imaging Note 7 SieClear multi-view spatial compounding Note 8 Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) --- (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 519(k) Number ... K/Na 194 {10}------------------------------------------------ 510(k) Number (if known): K061946 Device Name: Intended Use: EC9-4 Convex Array Endocavity Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Abdominal | | | | | | | | | | | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Note 1) | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Neonatal Cephalic | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic Imaging Note 3 3D imaging Note 4 B&W SieScape panoramic imaging Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent Imaging Note 8 SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number K061946 {11}------------------------------------------------ 510(k) Number (if known): **Device Name:** Intended Use: K D61946 EV9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Abdominal | | | | | | | | | | | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Note 1) | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Neonatal Cephalic | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 3D Imaging B&W SieScape panoramic imaging Note 4 Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent imaging Note 8 SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging > (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) > > Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Divisi Reproductive, Abdominal and Ra cal Device 510(k) {12}------------------------------------------------ 510(k) Number @r known): **Device Name:** K061946 Intended Use: VF13-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | N | N | N | | N | N | | BMDC | Note 2.3.4.5.7.8.9 | | Abdominal | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Small Organ (Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Musculo-skeletal Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E For example: breast, testes, thyroid, penis, prostate, etc. Note 1 Ensemble tissue harmonic imaging Note 2 Note 3 3D Imaging B&W SieScape panoramic imaging Note 4 Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent Imaging Note 8 SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal Division of Reproductive, Abdominal, and Radiological Device 510(k) Number_ {13}------------------------------------------------ 510(k) Number (if known): K061946 P8-4 Phase Array Transducer for use with: Device Name: Intended Use: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | | | Mode of Operation | | | | | | | | | |----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,45,7,8,9 | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Small Organ (Note 1) | | | | | | | | | | | | Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethrai | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016(P7-4); E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 3D Imaging B&W SieScape panoramic imaging Note 4 Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent imaging Note 8 SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Y. Yamazak (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number {14}------------------------------------------------ 510(k) Number (if known): K061946 Device Name: Intended Use: ACUSON X300 Diagnostic Ultrasound Systems Diaqnostic imaging or fluid flow analysis of the human body as follows: BE9-4 Convex Array Transducer for use with: | | Mode of Operation | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Abdominal | | | | | | | | | | | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Note 1) | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Neonatal Cephalic | | N | N | N | | N | N | | BMDC | Note 2,3,4,5,7,8,9 | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,9 | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K043016; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 3D imaging Note 4 B&W SieScape panoramic Imaging Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent imaging SieClear multi-view spatial compounding Note 8 Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number {15}------------------------------------------------ 510(k) Number (if known): K061746 Device Name: Intended Use: CW2 Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | P | | | | | | | | Abdominal | | | | | P | | | | | | | | Intraoperative (Note 6) | | | | | P | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | P | | | | | | | | Small Organ (Note 1) | | | | | P | | | | | | | | Neonatal Cephalic | | | | | P | | | | | | | | Adult Cephalic | | | | | P | | | | | | | | Cardiac | | | | | P | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral vessel | | | | | P | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | P | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N = new indication; P = previously cleared under K001400; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic Imaging Note 3 3D imaging B&W SieScape panoramic imaging Note 4 Note 5 Power SieScape panoramic Imaging - For example: abdominal, vascular Note 6 Contrast agent imaging Note 7 Note 8 SieClear multi-view spatial compounding Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) D. Lawrence Harrington (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dey 510(k) Number {16}------------------------------------------------ 510(k) Number (if known): K061946 Device Name: Intended Use: CW5Continuous Wave Doppler Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | P | | | | | | | Abdominal | | | | | P | | | | | | | Intraoperative (Note 6) | | | | | P | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | P | | | | | | | Small Organ (Note 1) | | | | | P | | | | | | | Neonatal Cephalic | | | | | P | | | | | | | Adult Cephalic | | | | | P | | | | | | | Cardiac | | | | | P | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral vessel | | | | | P | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | P | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N = new indication; P = previously cleared under K023720; E = added under Appendix E For example: breast, testes, thyroid, penis, prostate, etc. Note 1 Note 2 Ensemble tissue harmonic Imaging Note 3 3D imaging Note 4 B&W SieScape panoramic imaging Power SieScape panoramic imaging Note 5 For example: abdominal, vascular Note 6 Note 7 Contrast agent imaging SieClear multi-view spatial compounding Note 8 Tissue Equalization Technology Note 9 Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Division Size: 080 (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number {17}------------------------------------------------ 510(k) Number (if known): Device Name: Intended Use: K061746 ## Acu Nav 8F Intracardiac Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | |----------------------|-------------------| |----------------------|-------------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |-------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (Note 6) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Note 1) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | P | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9 | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | P | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 | | Peripheral vessel | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (Intra-Cardiac) | P | P | P | P | P | P | P | | BMDC | Note 2,3,7,8,9,10 | N = new indication; P = previously cleared under K042593; E = added under Appendix E Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 3D imaging Note 4 B&W SieScape panoramic imaging Note 5 Power SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 7 Contrast agent imaging SieClear multi-view spatial compounding Note 8 Note 9 Tissue Equalization Technology Note 10 Intracardiac imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) limitation (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological De 510(k) Number K961946 {18}------------------------------------------------ 510(k) Number (if known): Device Name: 06194 Intended Use: Acu Nav 10F Intracardiac Transducer for use with : ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: | | Mode of Operation | | | | | | | | | | | | |----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | | | | Ophthalmic…