(84 days)
The SonoScape S11 device 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.
The SonoScape S11 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.
The provided 510(k) summary is for a diagnostic ultrasound system, which is a hardware device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to recognized safety standards, rather than clinical performance metrics often associated with AI/ML-enabled devices.
Therefore, many of the requested criteria (acceptance criteria related to clinical performance, specific study types like MRMC, sample sizes for test/training sets, ground truth establishment, or expert qualifications) are not applicable or detailed in this document. The submission asserts substantial equivalence based on comparisons of design, function, and safety characteristics with a predicate device.
Here's a breakdown of what can be extracted and what is not provided based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, or specificity, as it's an ultrasound hardware device submission focused on substantial equivalence rather than a new clinical claim. Its "performance" is implicitly deemed acceptable if it meets the technical specifications and safety standards, and is substantially equivalent to the predicate.
The table below summarizes the comparison items where "SE" (Substantially Equivalent) is indicated, implying the proposed device meets the predicate's performance in those aspects.
| Comparison Item | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|---|
| Classification Name | Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer | Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer | SE |
| Product Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | SE |
| Regulation Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | SE |
| Panel | Radiology | Radiology | SE |
| Class | II | II | SE |
| Intended Use | General-purpose ultrasonic imaging for 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. | The same intended uses, with the addition of one more probe (C354) that does not introduce new intended uses, maintaining substantial equivalence. | SE |
| Probe Type & Connectors | L741, L742, L743 Linear Array; C344, C362 Curved Array; C611, 6V1, 6V3, EC9-5 Micro-curved Array; 2P1, 5P1 Phased Array. Multi-port connector connects 2 transducers. | Includes all predicate probes plus C354 (Curved Array, 2.0-5.0 MHz). Multi-port connector connects 3 transducers. | SE (Analysis 1, 2) |
| Acoustic Track | TRACK 3 | TRACK 3 | SE |
Design (Functions Comparison - Excerpt) | Based on embedded Linux OS, 64 channel full digital beam former, Autocorrelation for color/FFT for pulse/CW Doppler, supports Linear, Curve linear and Phase array probes from 2 to 15 MHz, Cine play back, Image file archive, Software upgrades with USB, Digital Scan Converter 800x600, TGC 8 slider, Depth Range 3 to 32 cm, Image sector size 32 lines to full B (256 lines), Image Sector position Steering. | Same as predicate. | SE |
| Operation Modes | B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, 3D/4D Mode, Color M Mode. | B, M, PW, CW, CFM, DPI, TDI, Tissue Harmonic Image, 4D Mode, Color M Mode. (Note: 3D function is present in predicate but not explicitly listed for proposed device, addressed in SE Analysis 3). | SE (Analysis 3 specifies absence of 3D function but deems SE) |
| Display Modes | Dual B, Quad Display, B and M, B and Doppler, B + Color, Dual B (Flow), Triplex mode, Compound Imaging, Panoramic Imaging, Trapezoid Imaging. | Same as predicate. | SE |
| Measurement Items | Distance; area; circumference; calipers; volume, velocity, HR, PI, RI. Cardiac. OB/GYN, Urology, Vascular and small part package | Same as predicate. | SE |
| Cine Loop | Automatic/manual review. Review speed can be adjusted. | Automatic/manual review. Review speed can't be adjusted. | SE |
| Power Supply | Voltage: 110-240 VAC, Frequency: 50/60 Hz, Power Consumption: 2.7-1.2A | Voltage: 100-240 VAC, Frequency: 50/60 Hz, Power Consumption: 2.7-1.2A | SE (Analysis 4) |
| Operating Condition | Temperature: 10-40°C, Relative humidity: 30-85%, Air pressure: 700-1060hPa | Same as predicate. | SE |
| Storage Condition | Temperature: -20-55°C, Relative humidity: 20-90%, Air pressure: 700-1060hPa | Same as predicate. | SE |
| Screen Size | 15 inch Widescreen LCD monitor | Same as predicate. | SE |
| Acoustic Output | Track 3: MI,TIS,TIC,TIB, Derated ispta: 720Mw/cm² maximum, TIS/TIB/TIC: 6.0 Maximum, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190W/cm² max | Same as predicate. | SE |
| Electrical Safety | IEC 60601-1 | Same as predicate. | SE |
| EMC | IEC 60601-1-2 | Same as predicate. | SE |
| Performance | IEC 60601-2-37 | Same as predicate. | SE |
| Biocompatibility | ISO 10993-5, ISO 10993-10 | Same as predicate. | SE |
| Level of Concern of Software | Moderate level of concern system | Same as predicate. | SE |
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 explicitly states "No clinical testing was required." Therefore, there is no information on sample size for a test set or data provenance related to clinical data. The testing mentioned in Section 7 refers to "Laboratory testing" to verify design specifications and compliance with safety standards, which is not a clinical test set.
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)
Not applicable, as no clinical testing or test set requiring ground truth was conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing or test set requiring adjudication was conducted for this submission.
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
Not applicable. This device is a diagnostic ultrasound system, not an AI-enabled device designed to assist human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device; it does not perform as a standalone algorithm in the sense of AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing or test set requiring ground truth was conducted for this submission.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the context of AI/ML algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this hardware device.
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510(k) Summary
JUN 1 4 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number: __________________________________________________________________________________________________________________________________________________
-
- Date of submission: March 13, 2013
2. Submitter
SonoScape Company Limited
Address: Yizhe Building, Yuquan Road, Nanshan, Shenzhen 518051, P.R. China
Tel: (86) 755-26722890
Fax: (86) 755-26722850
Contact Person: Toki Wu
E-mail:Faith@sonoscape.net/wusq@sonoscape.net
3. Proposed Device Identification
Trade/Proprietary Name: S11 Digital Color Doppler Ultrasound System Common Name: Diagnostic Ultrasound System and Transducers Classification:
21 FR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
21 FR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
Classification Panel: Radiology
Device Class: II
4. Legally Marketed Predicate Device
SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K112602 (Decision Date - November 07, 2011).
510(k) Summary
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5. Device Description
The SonoScape S11 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 all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.
6. Intended Use Statement
The SonoScape S11 device 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.
7. Testing
Laboratory testing was conducted to verify that the S11 system with added transducer met all design specification and was substantially equivalent to the Predicate Device. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. The acoustic output is measured and calculated per "NEMA UID 2: 2004 Acoustic Output
510(k) Summary
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Measurement Standard for Diagnostic Ultrasound Equipment" and "NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment".
IEC 60601-1: 1988+A1:1991+A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. IEC 60601-2-37: 2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.
NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
8. Clinical Test:
No clinical testing was required.
9. Comparison Table
The differences between the S11 and the predicate device S6 in almost every part are listed in the tables below.
| ID | ComparisonItems | Proposed DeviceSonoscape S11 | Predicate DeviceSonoscape S6 | Remark |
|---|---|---|---|---|
| 2 | ClassificationName | Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed EchoImaging SystemDiagnostic UltrasoundTransducer | Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed EchoImaging SystemDiagnostic UltrasoundTransducer | SE |
| 3 | ProductCode | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | SE |
| ID | ComparisonItems | Proposed DeviceSonoscape S11 | Predicate DeviceSonoscape S6 | Remark |
| 4 | RegulationNumber | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | SE |
| 5 | Panel | Radiology | Radiology | SE |
| 6 | Class | II | II | SE |
| 1 | IntendedUse | The device is ageneral-purpose ultrasonicimaging instrument intended foruse by a qualified physician forevaluation of Fetal, Abdominal,Pediatric, Small Organ (breast,testes, thyroid), Cephalic(neonatal and adult),Trans-rectal, Trans-vaginal,Peripheral Vascular,Musculo-skeletal (Conventionaland Superficial), Cardiac(neonatal and adult), Urologyand OB/Gyn. | The device is ageneral-purpose ultrasonicimaging instrument intended foruse by a qualified physician forevaluation of Fetal, Abdominal,Pediatric, Small Organ (breast,testes, thyroid),Cephalic(neonatal and adult),Trans-rectal, Trans-vaginal,Peripheral Vascular,Musculo-skeletal (Conventionaland Superficial), Cardiac(neonatal and adult), OB/Gynand Urology. | SE |
| 7 | Probe Type&Connectors | L741 Linear Array, 5.0-10.0MHzL742 Linear Array, 5.0-12.0MHzL743 Linear Array, 5.0-10.0MHzC344 Curved Array, 2.0-5.0MHzC362 Curved Array, 2.0-6.0MHzC354 Curved Array, 2.0-5.0MHzC611 Micro-curved Array,4.0-8.0 MHzVC6-2 Curved Array, 2.0-6.0MHz6V1 Micro-curved Array,4.0-8.0 MHz6V3 Micro-curved Array,5.0-9.0 MHzEC9-5 Micro-curved Array,5.0-9.0 MHz | L741 Linear Array, 5.0-10.0MHzL742 Linear Array, 5.0-12.0MHzL743 Linear Array, 5.0-10.0MHzC344 Curved Array, 2.0-5.0MHzC362 Curved Array, 2.0-6.0MHzC611 Micro-curved Array,4.0-8.0 MHzVC6-2 Curved Array, 2.0-6.0MHz6V1 Micro-curved Array,4.0-8.0 MHz6V3 Micro-curved Array,5.0-9.0 MHzEC9-5 Micro-curved Array,5.0-9.0 MHz | SEAnalysis1SESESE |
| 2P1 Phased Array, 2.0-4.0 MHz | 2P1 Phased Array, 2.0-4.0 MHz | SE | ||
| ID | Comparison Items | Proposed DeviceSonoscape S11 | Predicate DeviceSonoscape S6 | Remark |
| 5P1 Phased Array, 4.0-7.0 MHz | 5P1 Phased Array, 4.0-7.0 MHz | |||
| Multi-port connector connects 3 transducers | Multi-port connector connects 2 transducers | SEAnalysis2 | ||
| 8 | Acoustic Track | TRACK 3 | TRACK 3 | SE |
Table 1 General Comparison
510(k) Summary
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SonoScape Company Limited
510(k) Submission
510(k) Summary
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SonoScape Company Limited
510(k) Submission
Table 2 Functions Comparison
| ID | ComparisonItems | Proposed DeviceSonoScape S11 | Predicate DeviceSonoScape S6 | Remark |
|---|---|---|---|---|
| 9 | Design | Based on an embedded Linuxoperating system.Based on a 64 channel fulldigital beam former.Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve linearand Phase array probes from 2to 15 MHz.Cine play back capabilityImage file archiveSoftware upgrades with USBflash drive.Digital Scan Converter800×600TGC 8 sliderDepth Range: 3 to 32 cmImage sector size: 32 lines tofull B (256 lines)Image Sector position: Steeringwithin full maximum | Based on an embedded Linuxoperating system.Based on a 64 channel fulldigital beam former.Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve linearand Phase array probes from 2to 15 MHz.Cine play back capabilityImage file archiveSoftware upgrades with USBflash drive.Digital Scan Converter800×600TGC 8 sliderDepth Range: 3 to 32 cmImage sector size: 32 lines tofull B (256 lines)Image Sector position: Steeringwithin full maximum | SE |
| 10 | OperationControls | B orientation flip :L/R key withmarking on the screenB Dynamic range control:preset 14 curves over 140 dBGray Scale Control: 7 SettingsFocal Number: 12 focal zonesettingB persistence: 0-95%Image Processing: Smoothing | B orientation flip :L/R key withmarking on the screenB Dynamic range control:preset 14 curves over 140 dBGray Scale Control: 7 SettingsFocal Number: 12 focal zonesettingB persistence: 0-95%Image Processing: Smoothing | SE |
| Comparison | Proposed Device | Predicate Device | ||
| ID | Items | SonoScape S11 | SonoScape S6 | Remark |
| edge enhancement | edge enhancement | |||
| PW sweeping speed 2,4,6,8 | PW sweeping speed 2,4,6,8 | SE | ||
| sec over display | sec over display | |||
| PW Wall filter setting: 16 | PW Wall filter setting: 16 | SE | ||
| settings,25 to 750 HZ | settings,25 to 750 HZ | |||
| PW sample volume:0.5 to | PW sample volume:0.5 to | SE | ||
| 20mm | 20mm | |||
| PW/B update: with UPDATE | PW/B update: with UPDATE | SE | ||
| key | key | |||
| PW cursor steering: Steer soft | PW cursor steering: Steer soft | SE | ||
| key | key | |||
| PW angle correction:0 to 80 | PW angle correction:0 to 80 | SE | ||
| degree user control | degree user control | |||
| PW spectrum dynamic | PW spectrum dynamic | SE | ||
| range: 10 preset curve over | range:10 preset curve over | |||
| 15-48 dB | 15-48 dB | |||
| Spectrum baseline shift and | Spectrum baseline shift and | SE | ||
| invert | invert | |||
| Color ROI setting: trackball and | Color ROI setting: trackball and | SE | ||
| set key to control size and | set key to control size and | |||
| position | position | |||
| Color steering on flat probe:±20 | Color steering on flat probe:±20 | SE | ||
| ±160 | ±160 | |||
| Color Wall Filter: Color wall | Color Wall Filter: Color wall | SE | ||
| filter with 16 selection, 25-750 | filter with 16 selection, 25-750 | |||
| of PRF | of PRF | |||
| Color priority-B priority soft | Color priority-B priority soft | SE | ||
| menu | menu | |||
| Color Packet size: preset per | Color Packet size: preset per | SE | ||
| Exam, horizontal, vertical, off | Exam, horizontal, vertical, off | |||
| Zoom adjustable | Zoom adjustable | SE | ||
| Freeze control: Toggling freeze | Freeze control: Toggling freeze | SE | ||
| key | key | |||
| Cine control: step, play | Cine control: step, play | SE | ||
| backward, play continuously | backward, play continuously | |||
| 11 | Operation | B, M, PW, CW, CFM, DPI, TDI, | B, M, PW, CW, CFM, DPI, TDI, | SE |
| Mode | Tissue Harmonic Image | Tissue Harmonic Image | Analysis | |
| 4D Mode | 3D/4D Mode | 3 | ||
| Color M Mode | Color M Mode | |||
| 12 | Display | Dual B, Quad Display, | Dual B, Quad Display, | SE |
| Modes | B and M, B and Doppler | B and M, B and Doppler | ||
| ID | ComparisonItems | Proposed DeviceSonoScape S11 | Predicate DeviceSonoScape S6 | Remark |
| B + Color, Dual B(Flow) | B + Color, Dual B(Flow) | |||
| Triplex mode: B,CFM, and | Triplex mode: B,CFM, and | |||
| PW/CW; B,DPI, and | PW/CW; B,DPI, and | |||
| PW/CW;B,THI and Color M,steer M | PW/CW;B,THI and Color M,steer M | |||
| Dual B and Color in real time | Dual B and Color in real time | |||
| Compound Imaging, | Compound Imaging, | |||
| Panoramic Imaging, | Panoramic Imaging, | |||
| Trapezoid Imaging. | Trapezoid Imaging. | |||
| 13 | Measurement Items | Distance; area; circumference; | Distance; area; circumference; | SE |
| calipers; volume, velocity, HR, | calipers; volume, velocity, HR, | |||
| PI, RI. Cardiac. OB/GYN, | PI, RI. Cardiac. OB/GYN, | |||
| Urology, Vascular and small | Urology, Vascular and small | |||
| part package | part package | |||
| 14 | Cine Loop | Automatic review/ manualreview | Automatic review/ manualreview | SE |
| Review speed can't be adjust | Review speed can be adjust | SE |
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SonoScape Company Limited
510(k) Submission
:
510(k) Summary
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SonoScape Company Limited
Table 3 Specifications Comparison
| ID | ComparisonItems | Proposed DeviceSonoScape S11 | Predicate DeviceSonoScape S6 | Remark |
|---|---|---|---|---|
| 15 | PowerSupply | Voltage: 100-240 VACFrequency: 50/60 HzPower Consumption:100-240V AC, 2.7-1.2A | Voltage: 110-240 VACFrequency: 50/60 HzPower Consumption: 110-240VAC, 2.7-1.2A | SEAnalysis4 |
| 16 | OperatingCondition | Temperature: 10 | Temperature: 10 | SE |
| 17 | StorageCondition | Temperature: -20 | Temperature: -20 | SE |
| 18 | Screen Size | 15 inch Widescreen LCDmonitor | 15 inch Widescreen LCDmonitor | SE |
| 19 | AcousticOutput | Track 3:MI,TIS,TIC,TIBDerated ispta: 720Mw/cm²maximum. | Track 3: MI,TIS,TIC,TIBDerated ispta: 720Mw/cm²maximum. | SE |
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SonoScape Company Limited
| ID | ComparisonItems | Proposed DeviceSonoScape S11 | Predicate DeviceSonoScape S6 | Remark |
|---|---|---|---|---|
| TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9Maximum, or Derated Isppa:190W/cm² max | TIS/TIB/TIC: 6.0 Maximum,Mechanical Index: 1.9Maximum, or Derated Isppa:190W/cm² max |
Table 4 Safety Comparison
| ID | ComparisonItems | Proposed DeviceSonoscape S11 | Predicate DeviceSonoscape S6 | Remark |
|---|---|---|---|---|
| 20 | Electrical Safety | -IEC 60601-1 | -IEC 60601-1 | SE |
| 21 | EMC | -IEC 60601-1-2 | -IEC 60601-1-2 | SE |
| 22 | Performance | -IEC 60601-2-37 | -IEC 60601-2-37 | SE |
| 23 | Biocompatibility | -ISO 10993-5,-ISO 10993-10 | -ISO 10993-5,-ISO 10993-10 | SE |
| 24 | Level ofConcern OfSoftware | Moderate level of concernsystem | Moderate level of concernsystem | SE |
SE Analysis 1
Compare to the predicate device, the proposed device is with one more probe C354. But the intended use of C354 is the same to the C344 and C362, no new intended use is added, therefore, the intended use could be considered Substantially Equivalent.
SE Analysis 2
The proposed device has 3 probe connection ports and the predicate device has 2 probe connection ports, but both of them comply with IEC 60601-1 and IEC 60601-1-2.
SE Analysis 3
Operation Mode, compare to the predicate device, the proposed device doesn't have 3D function. But both of them comply with AAMI UD2 and IEC 60601-2-37. Therefore, they are considered to be substantially equivalent, so the SE is not affected.
SE Analysis 4
The Voltage of the proposed device and the predicate device are 100-240 VAC and 110-240 VAC respectively, but both of them comply with IEC60601-1 and IEC 60601-1-2. Therefore, power supply can be considered Substantially Equivalent in safety and effectiveness.
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K130801
Page 9 of 9
Discussion of Substantially Equivalent
The subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
10. Substantially Equivalent Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S11 Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.
510(k) Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013 .
SonoScape Company Limited % Ms. Toki Wu Regulatory Affairs Manager Yizhe Building, Yuquan Road, Nanshan Shenzhen, Guangdong 518051 CHINA
Re: K130801
Trade/Device Name: S11 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: March 13, 2013 Received: March 22, 2013
Dear Ms. Wu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general-controls-provisions of the Act.include requirements.for annual_registration, listing_of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers for use with the SII Digital Color Doppler Ultrasound System, as described in your premarket notification:
Transducer Model Number
2P1 Phase Array 5P1 Phase Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array C362 Curved Array C344 Curved Array . C354 Curved Array VC6-2 Curved Array
L743 Linear Array L741 Linear Arrav L742 Linear Array
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Page 2 - Ms. Wu
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.hum.
-Sincerely-yours;-
Smh?)
for
Janine M. Morris Deputy Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K130801
Device Name: S11 Digital Color Doppler Ultrasound System
Indications for Use:
The SonoScape S11 device 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, Transvaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
-Over-The-Counter Use. -AND/OR-Prescription-Use .. (21-GFR-801-Subpart-C)-(Part 21-CFR 801-Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sm. 7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130801 510(k)
{12}------------------------------------------------
System: SonoScape S11
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 | ||
| 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 | ||
| Small Organ (specify) | N | N | N | N | N | Note 1 | Notes 2,5 | ||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Fetal | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3 |
| Imaging& | Trans-rectal | N | N | N | N | N | Note 1 | Notes 2 | |
| Other | Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2 | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2,4 | ||
| Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3 | |
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2 | |
| Vessel | Other (specify) |
E = added under this ppendix N = new indication; P = previously cleared by FDA; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130801
Indications for Use
{13}------------------------------------------------
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 Specific Color Power Other* Other* General CWD Combined (TRACKS 1 & 3) B M PWD Doppler (Amplitude) Specify (TRACK 1 Doppler ONLY) Ophthalmic Ophthalmic Fetal Fetal P P Notes 2 lmaging& Abdominal P P P Note 1 Other Intra-operative Specify Intra-operative Neuro Laparoscopic Pediatric Small Organ (specify) Neonatal Cephalic P P p P Note 1 Notes 2,3 P P P b P Note 1 Notes 2,3 P P P Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Other (Ob/GYN) Cardiac Adult P P P P P Note 1 Notes 2,3 Cardiac P P Cardiac Pediatric P P P P P Note 1 Notes 2,3 Intravascular(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/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130801
Indications for Use
{14}------------------------------------------------
" 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 | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph(non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
E = added under this appendix N = new indication; P = previously cleared by FDA; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color
Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 4: 4D Note 3: TDI
Note 5: Small Organ; breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130801
Indications for Use
{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 | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(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/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130801
{16}------------------------------------------------
Transducer: 6V3 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional)Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
E = added under this appendix P = previously cleared by FDA; N = new indication;
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________
Indications for Use
{17}------------------------------------------------
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 | |||||||||
| FetalImaging&Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral 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/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130801
{18}------------------------------------------------
Transducer: C611 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging&Other | Fetal | ||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | |
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (specify) |
E = added under this appendix N = new indication; P = previously cleared by FDA; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color
Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 4: 4D Note 3: TDI
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130801 510(k) -
{19}------------------------------------------------
Transducer: C362 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 | Fetal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Imaging & | Abdominal | P | P | P | P | P | Note1 | Notes 2 | |||
| Other | 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 | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note1 | Notes 2 | ||||
| Cardiac | Cardiac Adult | ||||||||||
| Cardiac Pediatric | |||||||||||
| Intravascular(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/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130801 510(k)
{20}------------------------------------------------
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 | Fetal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Imaging& | Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Other | 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 | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (specify) |
E = added under this appendix N = new indication; P = previously cleared by FDA; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)
Indications for Use
{21}------------------------------------------------
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 | |||||||||
| FetalImaging&Other | Fetal | N | N | N | N | N | Note 1 | Notes 2 | ||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2 | |||
| 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(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2 | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral 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/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130801 510(k)
Indications for Use
{22}------------------------------------------------
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 | Fetal | P | P | P | P | P | Note 1 | Notes 2,4 | |
| Imaging & | Abdominal | P | P | P | P | P | Note 1 | Notes 2.4 | |
| Other | 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(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2,4 | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (specify) |
P = previously cleared by FDA; N = new indication;
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130801 510(k)
Indications for Use
{23}------------------------------------------------
Transducer: L743 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | Other*Specify |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | Fetal | ||||||||
| Imaging& | Abdominal | ||||||||
| Other | Intra-operative Specify | ||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2 | |
| Vessel | Other (specify) |
E = added under this appendix P = previously cleared by FDA; N = new indication;
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 4: 4D Note 3: TDI
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________ K130801
Indications for Use
{24}------------------------------------------------
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 | Fetal | |||||||||
| Imaging& | Abdominal | |||||||||
| Other | Intra-operative Specify | |||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2.5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal | P | P | P | P | P | Note 1 | Notes 2 | |||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac)- | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2 | ||
| 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/THI; M/Color M ; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130801 510(k)
Indications for Use
{25}------------------------------------------------
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 | Other* | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(TRACK 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Combined | Specify | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging&Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| PeripheralVessel | Peripheral vesselOther (specify) | P | P | P | P | P | Note 1 | Notes 2 |
P = previously cleared by FDA; E = added under this appendix N = new indication; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; 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: 4D
Note 5: Small Organ: breast, thyroid, testes
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130801
Indications for Use
§ 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.