(23 days)
Not Found
No
The document describes a standard ultrasound system and does not mention any AI or ML capabilities.
No
The device is described as a "clinical diagnostic imaging system" used for "evaluation" and "diagnostic ultrasound system". It generates displays of "anatomic structures and fluid flow within the body" but does not mention any therapeutic capabilities.
Yes
The device description clearly states, "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."
No
The device description explicitly states it consists of a portable console with touch screen and keyboard control panel, power supply module, color LCD monitor, and optional probes, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The SonoScape S9 system is described as an ultrasound imaging system that transmits ultrasonic energy into the patient's body and processes the received echoes to generate images of internal structures and fluid flow. This is an in vivo diagnostic method, meaning it is performed within the living body.
- Intended Use: The intended use clearly lists various anatomical sites and applications for imaging within the body. There is no mention of analyzing samples taken from the body.
Therefore, the SonoScape S9 system, as described, is a diagnostic imaging device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
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. New probes Add 3C-A, 4P-A and 10l2 probes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Neonatal and Adult (from the Cephalic and Cardiac indications)
Intended User / Care Setting
Qualified physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests: 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 standards.
Clinical Test: No clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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 | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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 | |||||||||
| Peripheral | |||||||||
| Vessel |
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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 | ||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| 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) | ||||||||||
| Peripheral | ||||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 | ||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| 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) | ||||||||||
| Peripheral | ||||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 | ||||||||||
| Imaging& | ||||||||||
| 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 | ||||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 | Color
Doppler | Power
(Amplitude)
Doppler | Other*
Combined | Other*
Specify |
|------------------------------|------------------------------------|---|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General
(TRACK 1
ONLY) | Specific
(TRACKS 1 & 3) | B | M | PWD | CWD | Color
Doppler | 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 | | | | | | | | |
| Fetal
Imaging&
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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 | ||||||||||
| Imaging& | ||||||||||
| 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) | ||||||||||
| Peripheral | ||||||||||
| Vessel | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 | ||||||||||
| Imaging& | ||||||||||
| 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) | ||||||||||
| Peripheral | ||||||||||
| Vessel | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Combined | Specify | |||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 | ||||||||||
| Imaging& | ||||||||||
| 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| 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) | |||||||||
| Peripheral | |||||||||
| Vessel | 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 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | 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 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | 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 | Color
Doppler | | | Power
(Amplitude)
Doppler |
| General
(TRACK 1
ONLY) | Ophthalmic | | | | | | | | |
| Fetal
Imaging&
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) | | | | | | | | |
| Peripheral
Vessel | 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 device
SonoScape S9 | Predicate Device
Legally marketed
SonoScape S9 (K142710) | Remark |
|--------------------------------------------|----------------------------------------------------------------|-------------------|
| C322 Micro-curved Array | C322 Micro-curved Array | |
| C344 Curved Array | C344 Curved Array | |
| C353 Curved Array | C353 Curved Array | SE
Analysis1a) |
| 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 | SE
Analysis1b) |
| 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 | SE
Analysis1c) |
| 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 MHz
Continuous Wave Doppler | CWD5.0, 5.0 MHz
Continuous Wave Doppler | Same |
| PWD2.0, 2.0 MHz
Pulsed Wave Doppler | PWD2.0, 2.0 MHz
Pulsed 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.