(23 days)
The SonoScape S9 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
This SonoScape S9 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a portable console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D. The subject of this submission is the addition of new probes to legally marketed SonoScape S9.
The provided text is a 510(k) Summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. It outlines the device's technical characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device. It is for an ultrasound system, not an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to a predicate device (SonoScape S9 Portable Digital Color Doppler Ultrasound System K142710) based on similar intended uses, technical characteristics, and compliance with safety standards for an ultrasound machine and its transducers. It explicitly states: "No clinical testing was required." and "Laboratory tests (including Phantom tests) were conducted to verify that the S9 system met all design specifications and the S9 system conformed to applicable medical device standards." This indicates a traditional medical device clearance pathway, not one typically involving the robust performance validation studies seen with AI/ML devices.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2015
SONOSCAPE MEDICAL CORP. c/o Toki Wu Regulatory Affairs Manager 4/F, 5/F, 8/F, 9/F & 10/F, YIZHE BUILDING YUQUAN ROAD, NANSHAN SHENZHEN 518051 CHINA
Re: K152165
Trade/Device Name: S9 Portable Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 28, 2015 Received: August 3, 2015
Dear Ms. Wu:
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,
Robert A. Ochs
Robert A. Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
S9 Portable Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoScape S9 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
| _ Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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}------------------------------------------------
SonoScape S9 System:
Diagnostic Ultrasound Pulsed Echo System
Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6,7 | ||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Fetal | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| Imaging& | Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Other | Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1 | Notes 2,4 |
| Vessel | Cerebral vascular | P |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{4}------------------------------------------------
Transducer: C322 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular |
P = previously cleared by FDA; N = new indication; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{5}------------------------------------------------
Transducer: C344 Curved Array
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{6}------------------------------------------------
Transducer: C353 Curved Array
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | |||||||||
| Cerebral vascular | |||||||||
| PeripheralVessel |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{7}------------------------------------------------
Transducer: C542 Curved Array
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{8}------------------------------------------------
Transducer: 3C-A Curved Array
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | E | E | E | E | E | Note 1 | Notes 2,4 | ||
| Abdominal | E | E | E | E | E | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | E | E | E | E | E | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{9}------------------------------------------------
Transducer: VC6-2 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{10}------------------------------------------------
Transducer: C613 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{11}------------------------------------------------
Transducer: 2P2 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| FetalImaging&Other | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{12}------------------------------------------------
Transducer: 3P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| FetalImaging&Other | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Cardiac | Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{13}------------------------------------------------
Transducer: 5P2 Phase Array
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{14}------------------------------------------------
Transducer: 8P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{15}------------------------------------------------
Transducer: 4P-A Phase Array
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | E | E | E | E | E | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | E | E | E | E | E | E | Note 1 | Notes 2,3,4 | |
| Fetal | Adult Cephalic | E | E | E | E | E | E | Note 1 | Notes 2,3,4 |
| lmaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | E | E | E | E | E | E | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | E | E | E | E | E | E | Note 1 | Notes 2,3,4 | |
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{16}------------------------------------------------
Transducer: L741 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | |||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{17}------------------------------------------------
Transducer: L742 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | ||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{18}------------------------------------------------
Transducer: L743 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{19}------------------------------------------------
Transducer: L752 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6,7 | ||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{20}------------------------------------------------
Transducer: 10L1 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | |||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{21}------------------------------------------------
Transducer: 1012 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | E | E | E | E | E | Note 1 | Notes 2,4,6 | |||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | E | E | E | E | E | Note 1 | Notes 2,4 | |||
| Musculo-skeletal(Superficial) | E | E | E | E | E | Note 1 | Notes 2,4 | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | E | E | E | E | E | Note 1 | Notes 2,4 | ||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{22}------------------------------------------------
Transducer: 6V1 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{23}------------------------------------------------
Transducer: 6V3 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{24}------------------------------------------------
Transducer: EC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{25}------------------------------------------------
Transducer: BCC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{26}------------------------------------------------
Transducer: BCL10-5 Biplane Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other* | |||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined | Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{27}------------------------------------------------
Transducer: MPTEE Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | P | P | P | P | P | P | ||||
| Cardiac | Trans-esoph.(Cardiac) | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{28}------------------------------------------------
Transducer: MPTEE mini Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{29}------------------------------------------------
Transducer: LAP7 Linear Array
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{30}------------------------------------------------
Transducer: CWD2.0
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | P | |||||||||
| Cardiac Pediatric | P | |||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{31}------------------------------------------------
Transducer: CWD5.0
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | P | ||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | P | |||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{32}------------------------------------------------
Transducer: PWD2.0
Diagnostic Ultrasound Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Specific(TRACKS 1 & 3) | Mode of Operation | Other*Combined | Other*Specify | |||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ||||
| General(TRACK 1ONLY) | Ophthalmic | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Cerebral vascular | P |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{33}------------------------------------------------
510(k) Summary
1. Submitter [21 CFR807.92 (a) (1)]
| Submitter: | SONOSCAPE MEDICAL CORP. |
|---|---|
| Address: | 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051, P.R.China |
| Contact Person: | Toki Wu |
| Tel: | +86 755 26722890 |
| Fax: | +86 755 26722850 |
| Email: | wusq@sonoscape.net |
| Date Prepared | July 28, 2015 |
2. Device [21 CFR807.92 (a) (2)]
| Trade Name: | S9 Portable Digital Color Doppler Ultrasound System |
|---|---|
| Common Name: | Diagnostic Ultrasound System and Transducers |
Classification Regulatory:
| FR Number | Product Code | |
|---|---|---|
| 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 |
Classification Panel: Radiology Device Class: ll
3. Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicate device within this submission is as follows: SonoScape S9 Portable Digital Color Doppler Ultrasound System K142710
4. Device Description [21 CFR 807.92(a) (4)]
This SonoScape S9 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of
{34}------------------------------------------------
anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a portable console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
The subject of this submission is the addition of new probes to legally marketed SonoScape S9.
New probes Add 3C-A, 4P-A and 10l2 probes.
5. Intended Use [21 CFR 807.92(a) (5)]
The SonoScape S9 system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
6. Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]
S9 Portable Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:
SonoScape S9 Portable Digital Color Doppler Ultrasound System K142710
Intended Use Comparison:
Compared with legally marketed SonoScape S9 (K142710), the Subject Device S9 has the same intended uses.
Technical Characteristics Comparison:
The basic and key technical features of the Subject Device S9 are the same as the legally marketed SonoScape S9 (K142710), including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Power Supply, Operating and Storage Condition and Screen Size.
The detailed technical features can be found in General Device Descriptions of this
510(k) Summary
{35}------------------------------------------------
submission.
Probes Comparison:
Subject device S9 has the similar probes as the legally marketed SonoScape S9 (K142710).
| Subject deviceSonoScape S9 | Predicate DeviceLegally marketedSonoScape S9 (K142710) | Remark |
|---|---|---|
| C322 Micro-curved Array | C322 Micro-curved Array | |
| C344 Curved Array | C344 Curved Array | |
| C353 Curved Array | C353 Curved Array | SEAnalysis1a) |
| C542 Curved Array | C542 Curved Array | |
| 3C-A Curved Array | ||
| VC6-2 Curved Array | VC6-2 Curved Array | Same |
| C613 Micro-curved Array | C613 Micro-curved Array | Same |
| 2P2 Phased Array | 2P2 Phased Array | |
| 3P1 Phased Array | 3P1 Phased Array | |
| 5P2 Phased Array | 5P2 Phased Array | SEAnalysis1b) |
| 8P1 Phased Array | 8P1 Phased Array | |
| 4P-A Phased Array | ||
| L741 Linear Array | L741 Linear Array | |
| L742 Linear Array | L742 Linear Array | |
| L743 Linear Array | L743 Linear Array | SEAnalysis1c) |
| L752 Linear Array | L752 Linear Array | |
| 10L1 Linear Array | 10L1 Linear Array | |
| 1012 Linear Array | ||
| 6V1 Micro-curved Array | 6V1 Micro-curved Array | |
| 6V3 Micro-curved Array | 6V3 Micro-curved Array | |
| EC9-5 Micro-curved Array | EC9-5 Micro-curved Array | |
| BCC9-5 Micro-curved Array | BCC9-5 Micro-curved Array | Same |
| BCL10-5 Biplane (Curved +Linear Array) | BCL10-5 Biplane (Curved +Linear Array) | |
| MPTEE Phased Array(Multi-plane) | MPTEE Phased Array(Multi-plane) | |
| MPTEE mini Phased Array(Multi-plane) | MPTEE mini Phased Array(Multi-plane) | Same |
| LAP7, Linear Array | LAP7, Linear Array | Same |
| CWD2.0, 2.0 MHz | CWD2.0, 2.0 MHz | |
| CWD5.0, 5.0 MHzContinuous Wave Doppler | CWD5.0, 5.0 MHzContinuous Wave Doppler | Same |
| PWD2.0, 2.0 MHzPulsed Wave Doppler | PWD2.0, 2.0 MHzPulsed Wave Doppler | Same |
| Table 1 Probes Comparison | |
|---|---|
510(k) Summary
{36}------------------------------------------------
SE Analysis 1:
Compared with the legally marketed SonoScape S9 (K142710), there are three additional probes for the subject device, which are 3C-A, 4P-A and 10I2.
- a) The performance and clinical application of 3C-A probe are the same as C344; and though the frequency of them is slightly different, they both meet the clinical use.
- b) The performance and clinical application of 4P-A probe are the same as 3P1; and though the frequency of them is slightly different, they both meet the clinical use.
- c) The frequency, performance and clinical application of 1012 probe are the same as L741.
Note: detailed description information about the new probes can be found in Substantial Equivalence Comparison.
Moreover, compared with predicated device, the subject device (S9) complies with the same regulation and safety standards and has the consistent acoustic output levels. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
7. Non-Clinical Tests [21 CFR 807.92(b) (1)]
The S9 Portable Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
Laboratory tests (including Phantom tests) were conducted to verify that the S9 system met all design specifications and the S9 system conformed to applicable medical device
The S9 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.
8. Clinical Test [21 CFR 807.92(b) (2)]
No clinical testing was required.
9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]
In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SONOSCAPE MEDICAL CORP. concludes that S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.
standards.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.