(107 days)
The SonoScape S12 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
This SonoScape S12 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 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, 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.
This document describes the safety and performance evaluations for the SonoScape S12 Digital Color Doppler Ultrasound System (K142474) and its transducers, in comparison to predicate devices, to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SonoScape S12 Digital Color Doppler Ultrasound System are primarily demonstrated through conformance to established international and national standards, and by showing substantial equivalence to predicate devices for its intended uses and technological characteristics. The document doesn't present a specific table of numerical performance acceptance criteria and reported performance values in a typical AI/software context. Instead, it relies on a comparison of technical specifications and functionalities with predicate devices.
However, based on the provided text, we can infer some "acceptance criteria" through comparison to predicate devices and adherence to standards. Since direct numerical performance metrics are not given, the "Reported Device Performance" for equivalence is qualitative, stating "Same" or "Substantially Equivalent (SE) with detailed analysis".
Here's a summarized view of the comparisons:
| Acceptance Criteria (Inferred from Predicate Device Features & Standards) | Reported Device Performance (SonoScape S12 vs. Predicate) | Basis for Equivalence/Conclusion |
|---|---|---|
| Design Characteristics: | ||
| Embedded Linux operating system | Same as SonoScape S8 Exp | Direct match |
| Autocorrelation for color processing, FFT for pulse and CW Doppler | Same as SonoScape S8 Exp | Direct match |
| Support for Linear, Curved, & Phased array probes (2-15 MHz) | Same as SonoScape S8 Exp | Direct match |
| Cine play back capability | Same as SonoScape S8 Exp | Direct match |
| Image file archive | Same as SonoScape S8 Exp | Direct match |
| Software upgrade with USB flash drive | Same as SonoScape S8 Exp | Direct match |
| Digital Scan Converter (800x600) | Same as SonoScape S8 Exp | Direct match |
| Full keyboard panel, TGC 8 slider | Same as SonoScape S8 Exp | Direct match |
| Operation Controls: | ||
| Depth Range (3-24.8 cm) | Same as SonoScape S8 Exp | Direct match |
| B Dynamic range (20-280 dB) | Same as SonoScape S8 Exp | Direct match |
| Gray Scale Control (7 optional) | Same as SonoScape S8 Exp | Direct match |
| Focal Number (adjustable, max 12) | Same as SonoScape S8 Exp | Direct match |
| B persistence (0-95%) | Same as SonoScape S8 Exp | Direct match |
| PW sweeping speed (2,4,6,8 sec) | Same as SonoScape S8 Exp | Direct match |
| PW Wall filter setting (35-750) | Same as SonoScape S8 Exp | Direct match |
| PW sample volume (0.7-21mm) | Same as SonoScape S8 Exp | Direct match |
| PW angle correction (0-72 degree) | Same as SonoScape S8 Exp | Direct match |
| Spectrum baseline (adjustable) | Same as SonoScape S8 Exp | Direct match |
| Color ROI setting (trackball & set key) | Same as SonoScape S8 Exp | Direct match |
| Color Wall Filter settings (35-750) | Same as SonoScape S8 Exp | Direct match |
| Zoom adjustable | Same as SonoScape S8 Exp | Direct match |
| Freeze control (Toggling freeze key) | Same as SonoScape S8 Exp | Direct match |
| Cine control (play/stop, loop speed, frame by frame) | Same as SonoScape S8 Exp | Direct match |
| Operation Modes & Functions: | ||
| B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, Color M Mode, PIH, Compound Imaging, 3D/4D Mode, Panoramic Imaging, Trapezoid Imaging | Same as SonoScape S8 Exp | Substantially Equivalent (SE Analysis 1 for Elastography) |
| Elastography Technique (Strain Elastography) | Same as Philips EPIQ | Substantially Equivalent (SE Analysis 1) |
| Elastography Clinical Applications (adjunct for hard/soft tissue, tumor discovery) | Same as Philips EPIQ | Substantially Equivalent (SE Analysis 1) |
| Elastography Functions (elasticity image generation, distance/area measurement, strain ratio calc) | Similar to Philips EPIQ | Substantially Equivalent (SE Analysis 1) |
| Display Modes: | ||
| Single, Dual, Quad for B,CFM,DPI,TDI, 4D; Dual Live for B+CFM, B+DPI, B+TDI; various split screens for B/M, CFM/M, TDI/M, Steer M, PW, CW | Same as SonoScape S8 Exp | Direct match |
| Measurement Items: | ||
| Various measurements for B, CFM, DPI, TDI (Area Ratio, Angle, Volume, etc.), M (Distance, Time, Slope, HR, etc.), PW/CW (Flow Velocity, Acceleration, Time, Trace, Auto Trace, HR, etc.) | Same as SonoScape S8 Exp | Direct match |
| Operating Conditions: | ||
| Temperature (10-40°C), Relative humidity (30-75%), Air pressure (700-1060 hPa) | Same as SonoScape S8 Exp | Direct match |
| Storage Conditions: | ||
| Temperature (-20-55°C), Relative humidity (20-90%), Air pressure (700-1060 hPa) | Same as SonoScape S8 Exp | Direct match |
| Power Supply: | ||
| Voltage (100-240V AC), Frequency (50/60 Hz), Power Consumption (2.7-1.1A) | Wider input voltage range, minor current difference compared to SonoScape S8 Exp (110-240 VAC, 2.7-1.2A) | Substantially Equivalent (SE Analysis 2), complies with IEC60601-1 |
| Screen Size: | ||
| 15 inch LCD monitor | Minor difference in screen size (vs. 15 inch Widescreen LCD monitor) compared to SonoScape S8 Exp | Substantially Equivalent (SE Analysis 3), complies with IEC60601-1 & IEC60601-1-2, meets clinical needs. |
| Compliance with Standards: | Meet IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3 | Verified through laboratory tests |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states, "Laboratory tests were conducted to verify that the S12 system met all design specifications... Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strain ratio measurement and etc."
However, the specific "sample size" for these laboratory and phantom tests (e.g., number of phantom measurements, specific dataset sizes) is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified/mentioned for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on technical specifications, direct comparison to predicate devices, and phantom testing, rather than human expert interpretation of images. The "phantom test" mentioned for Elastography implies a physical standard or controlled environment rather than expert-labeled cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Since the document does not describe the use of human experts or clinical data for a test set that would require ground truth adjudication, there is no adjudication method mentioned or applicable in the context presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done. The device is a diagnostic ultrasound system, and the submission focuses on establishing substantial equivalence based on technical characteristics and safety standards, not on AI-assisted diagnostic improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes a diagnostic ultrasound system and its transducers, which are hardware devices with embedded software for image acquisition and processing. It is not an AI-based standalone diagnostic algorithm. The phrase "algorithm only without human-in-the-loop performance" is not applicable in this submission. The system produces images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Elastography function (the only feature specifically mentioned with a "test"), the ground truth was established using phantom tests. This suggests a physical phantom with known properties (e.g., stiffness) was used as the reference, rather than expert consensus on clinical cases, pathology, or outcomes data. For other aspects of the ultrasound system, the "ground truth" seems to be adherence to engineering specifications and performance matching that of the predicate devices.
8. The sample size for the training set
The document is for a traditional diagnostic ultrasound system and does not mention machine learning or AI algorithms requiring a "training set." Therefore, no training set size is provided or applicable.
9. How the ground truth for the training set was established
As there is no mention of a training set (see point 8), the method for establishing its ground truth is also not applicable.
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Sonoscape Company Limited % Mr Toki Wu Regulatory Affairs Manager Yizhe Bldg., Yuquan Road, Nanshan Shenzhen 518051 P.R. CHINA
Re: K142474
Trade/Device Name: S12 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: August 29, 2014 Received: December 1, 2014
Dear Mr. 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 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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142474
Device Name
S12 Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoScape S12 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
{3}------------------------------------------------
System: SonoScape S12
Diagnostic Ultrasound Pulsed Echo System
Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Small Organ (specify) | N | N | N | N | N | Note 1 | Notes 2,4,6,7 | ||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| Fetal | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| Imaging& | Trans-rectal | N | N | N | N | N | Note 1 | Notes 2,4 | |
| Other | Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2,4 | |
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2,4,5 | ||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | |
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph. (Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2,4 | |
| Vessel | Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K142474
Indications for Use
{4}------------------------------------------------
Transducer: C322 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| 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) | P | 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 | Other (specify) |
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 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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K142474
Indications for Use
Page 3 of 17
{5}------------------------------------------------
Transducer: C344 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
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 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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K142474
Indications for Use
{6}------------------------------------------------
Transducer: C354 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | ||
| Ophthalmic | Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | ||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | ||||
| Intra-operative Specify | |||||||||||
| Intra-operative Neuro | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| 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) | 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 | Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{7}------------------------------------------------
Transducer: C542 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| 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) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{8}------------------------------------------------
Transducer: VC6-2 Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4,5 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (specify) |
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 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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K142474 510(k)
Indications for Use
{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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | ||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{10}------------------------------------------------
Transducer: 2P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| 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(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 | Peripheral vessel | |||||||||
| Vessel | Other (specify) |
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; 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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{11}------------------------------------------------
Transducer: 5P1 Phase Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | ||
| 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 | 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 | Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{12}------------------------------------------------
Transducer: L741 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6,7 | |||
| 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) | ||||||||||
| 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 | Other (specify) |
P = previously cleared by FDA; N = new indication; 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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{13}------------------------------------------------
Transducer: L742 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | |||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{14}------------------------------------------------
Transducer: 10L1 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,4,6 | ||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{15}------------------------------------------------
Transducer: 6V1 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| 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) | ||||||||||
| 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 | Peripheral vessel | |||||||||
| Vessel | Other (specify) |
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 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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K142474
Indications for Use
{16}------------------------------------------------
Transducer: EC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{17}------------------------------------------------
Transducer: BCC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| FetalImaging&Other | Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | |||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{18}------------------------------------------------
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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| FetalImaging&Other | Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
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
Note 7: Elastography
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
{19}------------------------------------------------
510(k) Summary
1. Submitter [21 CFR807.92 (a) (1)]
| Submitter: | SonoScape Company Limited |
|---|---|
| Address: | Yizhe Building, Yuquan Road, Nanshan, Shenzhen518051, P.R.China |
| Contact Person: | Toki Wu |
| Tel: | +86 755 26722890 |
| Fax: | +86 755 26722850 |
| Email: | wusq@sonoscape.net |
| Date Prepared | August 29, 2014 |
2. Device [21 CFR807.92 (a)(2)]
| Trade Name: | S12 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 devices within this submission are as follows: SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System K132768 Philips EPIQ Diagnostic Ultrasound System K132304
4. Device Description [21 CFR 807.92(a) (4)]
This SonoScape S12 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
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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 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, 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.
5. Intended Use [21 CFR 807.92(a) (5)]
The SonoScape S12 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
6. Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]
S12 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:
SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System K132768 Philips EPIQ Diagnostic Ultrasound System K132304
The basic and main technical features of the subject device S12 are the same as the predicated device S8 Exp (K132768), including Design, Operation Controls, Display Modes, Measurement Items, Cine Loop and Operating and Storage Condition.
For Operation Modes, the essential imaging modes and functions of the Subject Device S12 are identical as the Predicate Device S8 Exp (K132768), including B, M, PW, CW, CFM, DPI, TDI, Color M and 3D/4D Mode, and Tissue Harmonic Image, PIH, Compound Imaging, Panoramic Imaging and Trapezoid Imaging. The Elastography is a special Operation Mode for the Subject Device S12, but already employed by many marketed devices and considered Substantially Equivalent to the Predicate Device Philips EPIQ (K132304) and detailed analysis shown as the following.
There are some differences in the Power Supply and Screen Size, but considered Substantially Equivalent in safety and effectiveness and detailed analysis shown as the
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following.
| ID | ComparisonItems | Subject deviceSonoScape S12 | Predicate DeviceSonoScape S8 Exp | Remark |
|---|---|---|---|---|
| 1 | Design | Based on an embedded Linuxoperating system. | Based on an embedded Linuxoperating system. | Same |
| Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing. | Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing. | Same | ||
| Supporting Linear, Curve linearand Phase array probes from 2to 15 MHz. | Supporting Linear, Curve linearand Phase array probes from 2to 15 MHz. | Same | ||
| Cine play back capability | Cine play back capability | Same | ||
| Image file archive | Image file archive | Same | ||
| Software upgrade with USBflash drive. | Software upgrade with USBflash drive. | Same | ||
| Digital Scan Converter800x600 | Digital Scan Converter800×600 | Same | ||
| With full keyboard panelTGC 8 slider | With full keyboard panelTGC 8 slider | Same | ||
| 2 | OperationControls | Depth Range: 3 to 24.8cm | Depth Range: 3 to 24.8cm | Same |
| B Dynamic range control:20-280dB | B Dynamic range control:20-280dB | Same | ||
| Gray Scale Control: 1,2,3,4,5,6,7 (7 optional) | Gray Scale Control: 1,2,3,4,5,6,7 (7 optional) | Same | ||
| Focal Number: adjustable, max12 | Focal Number: adjustable, max12 | Same | ||
| B persistence:0-95% | B persistence: 0-95% | Same | ||
| PW sweeping speed 2,4,6,8sec over display | PW sweeping speed 2,4,6,8sec over display | Same | ||
| PW Wall filter setting: 35 to 750 | PW Wall filter setting: 35 to 750 | Same | ||
| PW sample volume:0.7 to21mm | PW sample volume:0.7 to21mm | Same | ||
| PW angle correction:adjustable, 0 to 72 degree | PW angle correction:adjustable, 0 to 72 degree | Same | ||
| Spectrum baseline: adjustable,such as shift and invertColor ROI setting: trackball andset key to control size andpositionColor Wall Filter settings: 35 to750 | Spectrum baseline: adjustable,such as shift and invertColor ROI setting: trackball andset key to control size andpositionColor Wall Filter settings: 35 to750 | Same | ||
| ID | ComparisonItems | Subject deviceSonoScape S12 | Predicate DeviceSonoScape S8 Exp | Remark |
| Zoom adjustable | Zoom adjustable | Same | ||
| Freeze control: Toggling freezekey | Freeze control: Toggling freezekey | Same | ||
| Cine control: play/stop, loopspeed, the start, the end,Frame by Frame | Cine control: play/stop, loopspeed, the start, the end,Frame by Frame | Same | ||
| 3 | OperationMode | B, M, PW, CW, CFM, DPI, TDI,Tissue Harmonic Image, ColorM Mode, PIH, CompoundImaging, 3D/4D ModePanoramic Imaging, TrapezoidImaging. | B, M, PW, CW, CFM, DPI, TDI,Tissue Harmonic Image, ColorM Mode, PIH, CompoundImaging, 3D/4D ModePanoramic Imaging, TrapezoidImaging. | SEAnalysis1 |
| 4 | DisplayModes | B,CFM,DPI,TDI, 4D: Single,Dual, QuadB+CFM,B+DPI,B+TDI: DualLiveB/M, CFM/M,TDI/M, Steer M:V1/3,V1/2(Dual),V2/3,H1/2,H1/4,01/4PW,CW:V1/3,V1/2(Dual),V2/3,H1/2,H1/4,01/4 | B,CFM,DPI,TDI, 4D: Single,Dual, QuadB+CFM,B+DPI,B+TDI: DualLiveB/M, CFM/M,TDI/M, Steer M:V1/3,V1/2(Dual),V2/3,H1/2,H1/4,01/4PW,CW:V1/3,V1/2(Dual),V2/3,H1/2,H1/4,01/4 | Same |
| 5 | MeasurementItems | B, CFM, DPI, TDI: Area Ratio,Angle, Volume, Volume L x W xH, Doppler Area, Vascular,Small Part, Ortho, OB/GYN,Cardiac, URO, VHE;M: Distance, Time, Slope, HR,Left Ventricle, Mitral Valve,Aortic Valve;PW/CW: Flow Velocity,Acceleration, Time, Trace,Auto Trace, HR, Vascular,OB/GYN, Cardiac, VE | B, CFM, DPI, TDI: Area Ratio,Angle, Volume, Volume L x W xH, Doppler Area, Vascular,Small Part, Ortho, OB/GYN,Cardiac, URO, VHE;M: Distance, Time, Slope, HR,Left Ventricle, Mitral Valve,Aortic Valve;PW/CW: Flow Velocity,Acceleration, Time, Trace, AutoTrace, HR, Vascular, OB/GYN,Cardiac, VE | Same |
| 6 | Cine Loop | Automatic review/ manualreviewReview speed can be adjusted | Automatic review/ manualreviewReview speed can be adjusted | Same |
| 7 | OperatingCondition | Temperature: 10 | Temperature: 10 | Same |
| 8 | StorageCondition | Temperature: -20 | Temperature: -20 | Same |
| ID | Comparison Items | Subject device SonoScape S12 | Predicate Device SonoScape S8 Exp | Remark |
| Air pressure: 700hPa ~1060hPa | Air pressure: 700hPa ~1060hPa | Same | ||
| 9 | Power Supply | Voltage: 100-240V AC | Voltage: 110-240 VAC | SEAnalysis2 |
| Frequency: 50/60 Hz | Frequency: 50/60 Hz | Same | ||
| Power Consumption: 100-240V AC, 2.7-1.1A | Power Consumption: 110-240V AC, 2.7-1.2A | SEAnalysis2 | ||
| 10 | Screen Size | 15 inch LCD monitor | 15 inch Widescreen LCD monitor | SEAnalysis3 |
Table 1 Technological Characteristics Comparison
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SE Analysis 1:
According to the following comparison of Elastography technique, clinical applications and functions, the Subject Device S12 has the same Elastography technique and clinical applications and similar functions as the Predicate Device Philips EPIQ (K132304). Therefore the Subject Device S12 can be considered Substantially Equivalent to the Predicate Devices in safety and effectiveness, and no new risk is raised, so the SE is not affected.
Table 2 Elastography Comparison
| ComparisonItems | Subject deviceSonoScape S12 | Predicate DevicePhilips EPIQ |
|---|---|---|
| ElastographyTechnique | Strain Elastography:In this technique, an externalcompression is applied to tissue, andthen physical compression results in a2D display of strain distribution inreal-time according to the differentelastic properties of body tissue andindicates relative stiffness. | Strain Elastography:In this technique, an externalcompression is applied to tissue, andthen physical compression results in a2D display of strain distribution inreal-time according to the differentelastic properties of body tissue andindicates relative stiffness. |
| ClinicalApplications | As an adjunct technique for clinicalpractice, the Elastography determinesif an area of tissue is hard or soft ascompared with its surroundings.Furthermore, it provides theElastography image to discover tumors(stiffer than the surrounding tissue).The Elastography image displays arange of map shades from the softest | Elastography is used clinically as anadjunct technique in a small partsimaging practice to determine if anarea of tissue is hard or soft ascompared with its surroundings. Theelastogram will display a range of mapshades from the softest tissue in theimage to the stiffest in a given field ofview. As a way of discovering tumors |
510(k) Summary
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| tissue in the image to the stiffest in a given field of view. | (tumors are stiffer than the surrounding tissue). | |
|---|---|---|
| Functions | Generating elasticity image. Perform the Distance and Area (Ellipse or Trace) measurement on either 2D or elasticity image and the measurement will auto populate to the other side, which help to assess and validate the size and location of lesion. Strain ratio allows calculation of relative strain of two interest regions (lesion, the surrounding tissue) which indicates the stiffness of the lesion indirectly. Other optimizing parameter and auxiliary function. | Generating Elastogram. Choose Ellipse, Trace, or Distance and perform the measurement on either 2D or Elasto first; the measurement will be copied onto the opposite image to validate size and location of lesion. Strain ratio allows calculation of relative strain of two regions of interest over time. Other adjusting parameter and auxiliary function. |
SE Analysis 2:
Power Supply, Compared with the predicate device, the subject device employs the same power type and has wider input voltage range and some differences in current range. But both them comply with the requirements of IEC60601-1 and include the voltage range in the United States. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
SE Analysis 3:
Screen Size, Compared with the predicate device, the subject device employs the same screen type and has some difference in screen size. But both of them comply with the requirements of IEC60601-1 & IEC60601-1-2 and meet clinical requirements. 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 S12 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
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Laboratory tests were conducted to verify that the S12 system met all design specifications and the S12 system conformed to applicable medical device standards. Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strainratio measurement and etc.
The S12 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 Company Limited concludes that S12 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.
§ 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.