P20 Series Digital Color Doppler Ultrasound System
Device Facts
| Record ID | K172993 |
|---|---|
| Device Name | P20 Series Digital Color Doppler Ultrasound System |
| Applicant | Sonoscape Medical Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Dec 5, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Digital Color Doppler Ultrasound 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, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
Device Story
P20 Series is a mobile, software-controlled, color diagnostic ultrasound system. It transmits ultrasonic energy into the body and processes received echoes to display anatomical structures and fluid flow. Input data is acquired via a wide array of probes (linear, convex, phased) operating between 1.0 MHz and 25.0 MHz. The system features a mobile console with a touch screen, keyboard, power module, and color LCD monitor. It supports B-Mode (including Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continuous Wave Doppler, Power Doppler, Elastography, and 3D/4D imaging. Used in clinical settings by qualified physicians, the system aids in diagnostic evaluation of various body systems. Output is displayed on the monitor for real-time clinical assessment, supporting diagnostic decision-making and patient management.
Clinical Evidence
No clinical data was required. Substantial equivalence was demonstrated through bench testing, including electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility, and acoustic output measurements, all conforming to recognized standards (IEC 60601 series, ISO 10993, AIUM/NEMA UD 2/3).
Technological Characteristics
Mobile console with touch screen/keyboard, color LCD monitor. Probes: linear, convex, phased arrays (1.0-25.0 MHz). Modes: B, M, TDI, Color/Power/PWD/CWD Doppler, Elastography, 3D/4D. Biopsy brackets: stainless steel (SUS 304). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5/10, AIUM/NEMA UD 2/3.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral vascular, muscular, musculo-skeletal, cardiac (pediatric/adult), trans-esophageal, laparoscopic, OB/GYN, and urology applications.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- SonoScape P50 Digital Color Doppler Ultrasound System (K170999)
Reference Devices
- SonoScape S45 (K160283)
- SonoScape X5 (K160258)
- Biopsy Brackets (K150045)
Related Devices
- K170999 — P50 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Jul 12, 2017
- K173058 — P10 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Dec 1, 2017
- K171000 — P60 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Jul 11, 2017
- K172082 — S60 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Sep 21, 2017
- K152396 — S12 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Sep 3, 2015
Submission Summary (Full Text)
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December 5, 2017
Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sonoscape Medical Corp. % Toki Wu Regulatory Affairs Manager 4/f, 5/f, 8/f, 9/f & 10/f Yizhe building, Yuquan Road, Nanshan Shenzhen 518051, GuangDong CHINA
Re: K172993
Trade/Device Name: P20 Series 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: November 16, 2017 Received: November 24, 2017
Dear Toki 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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
K172993
Device Name
P20 Series Digital Color Doppler Ultrasound System
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The Digital Color Doppler Ultrasound 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, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
| Over-The-Counter Use (21 CFR 801 Subpart C)<br> X Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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EF
PSC Publishing Services (301) 443-6740
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SonoScape P20, P20Pro, P15, P22, P25, P10 Plus 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>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<br>2,4,5,6,7 |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| Fetal<br>Imaging&<br>Other | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| | Trans-rectal | P | P | P | | P | P | Note 1 | Notes 2,4,5 |
| | Trans-vaginal | P | P | P | | P | P | Note 1 | Notes 2,4,5 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Musculo-skeletal<br>(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 2,4,5 |
| | 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) | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | 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/THI; 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
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### 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | 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 | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>Vessel | Other (specify) | | | | | | | | |
| | 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/THI; 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
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### 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 | Specific<br>(TRACKS 1 & 3) | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>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<br>Imaging&<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>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 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
{6}------------------------------------------------
Transducer: L752 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | N | N | N | N | N | N | Note 1 | Notes<br>2,4,6,7 |
| | Neonatal Cephalic | | | | | | | | |
| Fetal | Adult Cephalic | | | | | | | | |
| lmaging& | Trans-rectal | | | | | | | | |
| Other | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | Notes 2,4 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | 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 | N | N | N | N | N | N | 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 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
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Transducer: C1-6 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>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<br>Imaging&<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | Notes 2,4 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Cerebral vascular | | | | | | | | |
N = new indication; P = previously cleared by FDA;
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
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#### 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>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<br>Imaging&<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | Notes 2,4,5 |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(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 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
{9}------------------------------------------------
### 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 | | | | | | | Other* Combined | Other* Specify |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------|-----------------|----------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | | | |
| 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<br>Imaging&<br>Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>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 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{10}------------------------------------------------
### Transducer: 8P1 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>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) | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>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
{11}------------------------------------------------
#### Transducer: S1-5 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>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 | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 |
| Imaging& | Trans-rectal | | | | | | | | |
| Other | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(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 | 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 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 5: 4D
Note 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes
{12}------------------------------------------------
### Transducer: 7P-B 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2 |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 |
| Fetal | Adult Cephalic | | | | | | | | |
| Imaging& | Trans-rectal | | | | | | | | |
| Other | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 |
| | 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/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 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{13}------------------------------------------------
### 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<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | N | N | N | | N | N | Note 1 | Notes 2,6 |
| | Neonatal Cephalic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | Notes 2 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | Note 1 | Notes 2 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N…
