(160 days)
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed.
InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. 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.
The major features of the InnoSight diagnostic ultrasound:
- 64 Channel all digital beam former .
- Progressive dynamic receive focusing
- Wide band all digital demodulation
- Native frequency digital scan converter
- InnoSight diagnostic ultrasound can be hand carried for portable use
- Remote access image management through LAN port
- Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine mode
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm performance perspective. The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to predicate devices, safety considerations, and general technical specifications of an ultrasound system.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as they are not present in the given text.
The "Predicate Device Comparison" table lists various technical specifications and operating controls for the submitted device (InnoSight Diagnostic Ultrasound System) and two predicate devices (BenQ UP600 and Philips CX50 and Sparq). This comparison is used to demonstrate substantial equivalence to existing legally marketed devices, rather than establishing or proving specific performance acceptance criteria for a new, AI-driven functionality.
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December 13, 2017
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Qisda Corporation % Mr. Bob Leiker Owner/manager Leiker Regulatory & Quality Consulting 4157 North Del Rav Circle CLOVIS CA 93619
Re: K172056
Trade/Device Name: InnoSight Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: November 7, 2017 Received: November 14, 2017
Dear Mr. Leiker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION [510(k)] Summary
| Company Name: | Qisda CorporationNo.157,Shanying Rd.,Gueishan Dist.,Taoyuan City, Taiwan | |
|---|---|---|
| Contact: | Bob LeikerLeiker Regulatory & Quality Consulting4157 North Del Rey Circle in Clovis, CA 93619Telephone: (925) 556-1302Fax: (866) 718-3819E-mail: leiker-requlatory@comcast.net | |
| Device Name: | InnoSight Diagnostic Ultrasound System | |
| Common Name: | Diagnostic Ultrasound Imaging System | |
| Classification Name: | Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology | |
| Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNDiagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-ITX | ||
| Registration Number: 3010220244 | ||
| Factory Location: | Qisda CorporationNo.159,Shanying Rd.,Gueishan Dist.,Taoyuan City Taiwan |
Predicate Device Comparison:
The BenQ UP600 (K132690) and Philips CX50 and Sparq (K162329) are of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device.
| QisdaProduct Name510(k) Number | Predicate DeviceBenQ Medical Technology UP600 | Submission DeviceInnoSight Diagnostic Doppler Ultrasound | Predicate DeviceCX50 and Sparq Diagnostic Ultrasound Systems |
|---|---|---|---|
| K132690 | Pending | K162329 | |
| Qisda | Predicate Device | Submission Device | Predicate Device |
| Indications for Use | This device is a general-purpose ultrasonic imaginginstrument intended for use by a qualified physicianfor evaluation of Abdomen; Pediatric; Small Organ(breast, testes, thyroid); heart soft tissue; PeripheralVascular; Musculo-skeletal; Ob/Gyn and Urology. | InnoSight Diagnostic Ultrasound System is intended Philips CX50 and Sparq Diagnostic Ultrasoundfor diagnostic ultrasound imaging in B (2D),M-Mode, PW Doppler, CPA, Tissue Harmonicimaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal,trans-vaginal, Other (OB/GYN, Urology, Nerve),Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. | Systems are intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:Ophthalmic, Intraoperative, Laparoscopic, Fetal,Abdominal, Pediatric, Small Organ, Adult Cephalic,Neonatal Cephalic, Trans-vaginal, Musculo-skeletal,Gynecological, Cardiac Adult, Cardiac Pediatric,Trans-Esoph. (Cardiac), Intracardiac echo,Peripheral Vessel, Other (Carotid) |
| Design | Based on 128 channel full digital beam former. | Based on 64 channel full digital beam former. | Based on 128 channel full digital beam former. |
| Operating Controls | • Autocorrelation for color processing and FFT forpulse and CW Doppler processing.• Supporting both Linear, Curve linear and Phasearray probes from 1.5 to 10 MHz. | Autocorrelation for color processing and FFT forpulse and CW Doppler processing.Supporting both Linear, Curve linear and Phase array probes from 2 to 15 MHz. Cine play back capability and Image file archive Software upgrade with USB flash drive. Digital Scan Converter 1366x768 | Autocorrelation for color processing and FFT for pulse and CW Doppler processing.It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: |
| Cine play back capability and Image file archive | § TGC 8 slider, +/- 22.5 dB | * TGC 8 slider | |
| Software upgrade with USB flash drive. | § Depth Range: 1 to 28 cm | * Depth Range: 1 to 30 cm | |
| Digital Scan Converter 1024x768 | § Image sector size: 46 lines to full B (256 lines) | * Digital Scan Converter 1024x768 | |
| TGC 8 slider, +/- 24dB | § Image Sector position: Steering within full maximum | * B orientation flip: L/R invert key | |
| § Depth Range: 3 to 24 cm | § B orientation flip: L/R key with marking on the screen | * B Dynamic range control: Up to 170 dB | |
| § Image sector size: 32 lines to full B (256 lines) | § B Dynamic range control: preset 100 levels | * Image Processing: Smoothing, edge enhancement | |
| § Image Sector position: Steering within full maximum | § Gray Scale Control: 5 levels | * PW/B update: with UPDATE key | |
| § B orientation flip: L/R key with marking on the screen | § Focal Number: 10 focal zone setting | * PW cursor steering: Steer key | |
| § B Dynamic range control: preset 5 curves over 50-90 dB | § B persistence: 10 levels | * Spectrum baseline shift and invert | |
| § Gray Scale Control: 7 Settings | § Image Processing: Smoothing, edge enhancement | * Color ROI setting: trackball and set key to control size and position | |
| § Focal Number: 12 focal zone setting | § PW sweeping speed 1,2,4,8 sec over display. | * Freeze control: Touch freeze key | |
| § B persistence: 30-90% recursive | § PW Wall filter setting: 20 levels | * PW Wall filter setting | |
| § Image Processing: Smoothing, edge enhancement | § PW sample volume: 0.23 to 20 mm | * PW sample volume: 0.8 to 24.6mm | |
| § PW sweeping speed 2,4,8 sec over display. | § PW/B update: with UPDATE key | * Continuously variable steering in 2D, color Doppler, and Doppler modes | |
| § PW Wall filter setting: 15 settings, 0.25 to 20% of | § PW cursor steering: Steer key | * Color Wall Filter setting | |
| PRF | § PW angle correction: - 72,0,72 degree user control | * PW selectable sweep speeds | |
| § PW sample volume: 0.5 to 10mm with 0.5mm step size. | § PW spectrum dynamic range: 8 preset curve over 10-80 dB | * Spectrum normal/invert display around baseline | |
| § PW/B update: with UPDATE key | § Spectrum baseline shift and invert | * High definition zoom | |
| § PW cursor steering: Steer key | § M Process: Peak, Mean | * Cine control: step, play backward, play continuously | |
| § PW angle correction: 0 to 72 degree user control | § Color ROI setting: Touch and drag to control size | Color & B (echo) priority: controls for echo write priority | |
| § PW spectrum dynamic range: 5 preset curve over 15-48 dB | and position§ Color steering on flat probe: +/- 15 | ||
| § Spectrum baseline shift and invert | § Color Wall Filter: Color wall filter with 20 settings | ||
| § M Process: Peak, Mean | § Color & B priority: C-B priority Key | ||
| § Color ROI setting: trackball and set key to control size and position | § Color Packet size: preset per Exam range from 8 to 11 | ||
| § Color steering on flat probe: +/- 15 | § Zoom factor: Up to 5x | ||
| § Color Wall Filter: Color wall filter with 15 selection, 0.25-20% of PRF | § Freeze control: Touch freeze key | ||
| § Color & B priority: C-B priority soft menu | § Cine control: step, play backward, play continuously | ||
| § Color Packet size: preset per Exam range from 8 to 12§ Color spatial filter: preset per Exam, horizontal, vertical, off§ Zoom factor: 1.2, 1.5, 2, 2.5, 3, 4 | |||
| § Freeze control: Toggling freeze key | |||
| § Cine control: step, play backward, play continuously | |||
| Qisda | Predicate Device | Submission Device | Predicate Device |
| Safety Compliance | IEC 60601-1 International ElectrotechnicalComission; Medical Electrical Equipment - Part 1IEC60601-2 International ElectrotechnicalComission; Electromagnetic CompatibilityIEC 60601-2-37 International ElectrotechnicalComission; Medical Electrical Equipment - Part | IEC 60601-1 International ElectrotechnicalComission; Medical Electrical Equipment - Part 1IEC60601-2 International ElectrotechnicalComission; Electromagnetic CompatibilityIEC 60601-2-37 International ElectrotechnicalComission; Medical Electrical Equipment - Part | IEC 60601-1 International ElectrotechnicalComission; Medical Electrical Equipment - Part 1IEC60601-2 International ElectrotechnicalComission; Electromagnetic CompatibilityIEC 60601-2-37 International ElectrotechnicalComission; Medical Electrical Equipment - Part |
| Patient Contact Materials | 2-37RTV664+Ultrason S2010 silicon rubber complieswith ISO10993-5 and ISO10993-10 | 2-37Housing: P1700 and Valox420/ Lens: RTV 664 andRTV560/ Glue:KE45 are compliance with ISO | 2-37All patient contact materials of the CX50 UltrasoundSystem and transducers are detailed in K123754. |
| Operation Mode | B (2-D), M, CFM,CPA, PW, CW, Tissue HarmonicImage and combine mode | 10993-5 and ISO 10993-10B (2-D), M, CFM, CPA, PW,CW, Tissue HarmonicImage and combine mode | 2D Echo, M-mode, PW, CW, 2D Color, TissueTissue Doppler and Harmonics (Tissue andContrast) and Combination modes |
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode;2-D/Pulsed Doppler and Triplex 2-D/CD/PulsedDoppler image formats; Dual B and Color in real time | Single and dual 2-D; Display of Duplex 2-D/M-mode;2-D/Pulsed Doppler and Triplex 2-D/CD/PulsedDoppler image formats; Dual B and Color in real time | Single and dual 2-D; Display of Duplex 2-D/M-mode;2-D/Pulsed Doppler and Triplex 2-D/CD/PulsedDoppler image formats; Dual B and Color in real time |
| Display Annotations | Time/date/year; transducer type; power output in %;frames per second; persistence; and compressionsettings; image depth; patient name and ID;institution name; focal position; TGC curve display;Doppler & M scale in sec; Doppler angle correctioncursor; free form annotation anywhere on image;trackball controlled; selective or global erase of thedisplay annotations, body markers with transducerannotations | Time/date/year; transducer type; power output in %;frames per second; persistence; and compressionsettings; image depth; patient name and ID;institution name; focal position; TGC curve display;Doppler & M scale in sec; Doppler angle correctioncursor; free form annotation anywhere on image;trackball controlled; selective or global erase of thedisplay annotations, body markers with transducerannotations | transducer type and frequency, active clinicaloptions and optimized presets, display depth, TGCcurve, grayscale, color map, frame rate,compression map value, color gain, color imagemode, hospital name, and patient demographicdata, Scan plane orientation marker, User selectabledepth scale display, Multiple trackball-drivenannotation arrows, Pre-defined body markers. |
| Display Monitor | 15" LCD color monitor | 11.6" LCD Touch Screen | 15" LCD color monitor (CX50) |
| Measurements | Distance; area; Volume; circumference; Heart Rate;calipers; velocity; PI, RI, Cardiac, OB/GYN andVascular package. | Distance; area; Volume; circumference; Heart Rate;calipers; velocity; PI, RI, Cardiac, OB/GYN andVascular package. | Distance; area; Volume; circumference; Heart Rate;calipers; velocity; Pl, RI, Cardiac, OB/GYN andVascular package and QLAB quantification |
| Transducer Types &Connectors | Convex, Phase array, and Linear array probes;Multi-port connector connects up to 2 transducers | Convex, Phase array, and Linear array probes;Single-port connector connect 1 transducer | Convex, Phase array, Linear array, xMATRIX andCW probes, Single-port connector connect 1transducer (CX50), Multi-port connector connects upto 3 transducer (Sparq) |
| Transducer List | * C52* E94* L115* P42 | * C6-2* C9-4v* L12-4* S4-2 | * C6-2* C9-4v* L12-4* S4-2* C5-1* L5-7io* X7-2t* C8-5* C9-3io* C9-3v* C10-3v* D2 cwc* D5 cwc* L10-4lap* L12-3* L12-5* L15-7io* S2-4* S5-1* S7-3t* S8-3* St. Jude Medical ViewFlex Xtra |
| Principle of OperationUsers / Sites | Applying high voltage burst to the Piezoelectricmaterial in the transducer and detect the reflectedecho to construct the 2-D B-mode, Doppler color,and Doppler spectrum image for diagnostic purpose.Hospitals, clinics usage | Applying high voltage burst to the Piezoelectricmaterial in the transducer and detect the reflectedecho to construct the 2-D B-mode, Doppler color,and Doppler spectrum image for diagnostic purpose.Hospitals, clinics usage | Applying high voltage burst to the Piezoelectricmaterial in the transducer and detect the reflectedecho to construct the 2-D B-mode, Doppler color,and Doppler spectrum image for diagnostic purpose.Hospitals, clinics usage |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta:720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range,Mechanical Index: 1.9 Maximum, or Derated Isppa:190 W/cm2 max | Track 3; MI, TIS, TIC, TIB Derated Ispta:720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range,Mechanical Index: 1.9 Maximum, or Derated Isppa:190 W/cm2 max | Track 3; MI, TIS, TIC, TIB Derated Ispta:720mW/cm2 maximum, Mechanical Index: 1.9Maximum, Thermal Index: 6.0 Maximum |
| Labeling | Operator's Manual, brochure | Operator's Manual, brochure | Operator's Manual, brochure |
| Dimensions / Weight | Dimension: Height 36.1cm Width 36.3cm Depth18.7cm Weight: 9kg | Dimension: Height 223.2 mm Width 319.6 mmDepth 31.8 mm Weight: 2.46 kg | Dimension: Height 7.6 cm Width 41.3 cm Length35.6 mm Weight: 6.17 kg (CX50) |
| Power Requirements | Power requirements: 100 Volts AC, 2.5 Amps 120Volts AC, 2.1 Amps 230 Volts AC, 1.1 Amps 250Volts AC, 1 Amps Power Consumption: 180 watts,max Operating temperature 5-40° C; relative | Power requirements: 115 Volts AC, 1.14 Amps 230Volts AC, 0.79 Amps Power Consumption: 65 watts,max Operating temperature 10-40° C; relativehumidity 20-85%; | System/AC adapter 100-240V, 50/60 Hz, 250 VASystem with cart and peripherals 100-240V, 50/60Hz, 500 VA, max Operating temperature 10-40° C;relative humidity 15-95%; |
| Peripherals and Accessories | humidity 10-80%;LAN Picture quality Color Printer, USB flash mobiledrive , S-video output, VGA output | LAN, USB thermal Printer, USB flash mobile drive,HDMI video output | LAN, B/W and Color Printer, USB flash mobile drive,SVGA video output |
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and Triplex2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time. | ||
| Appendix I | Premarket Notification 510(k) Summary | Page 4 of 6 |
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General Device Description:
Appendix I
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InnoSight diagnostic ultrasound system is a compact and portable diagnostic ultrasound device, have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface is touch screen with 11.6" display. 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.
The major features of the InnoSight diagnostic ultrasound:
- 64 Channel all digital beam former .
- Progressive dynamic receive focusing
- Wide band all digital demodulation
- Native frequency digital scan converter
- InnoSight diagnostic ultrasound can be hand carried for portable use
- Remote access image management through LAN port
- Supports B (2-D), M, CFM, DPI, PW, Tissue Harmonic Image and combine mode
Intended Use:
InnoSight Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), M-Mode, PW Doppler, CPA, Tissue Harmonic imaging and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal, Abdominal, Small Organ (Breast, Thyroid, testes), trans-rectal, trans-vaginal, Other (OB/GYN, Urology, Nerve), Cardiac Adult and Peripheral Vessel. The clinical environments where the system can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The system is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the system user information, and only for the purposes for which it was designed.
The system should only be operated by someone who has received proper training in the use and operation of an ultrasound system. This system produces images derived from sound echoes; those images must be interpreted by a qualified medical professional. This system in no way interprets these images or provides a medical diagnosis of the patient being examined.
Technological Characteristics:
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| Description ofTransducers | InnoSight Diagnostic Ultrasound System withC6-2Curved Linear Array 2-6MHzL12-4Linear Array 4-12MHzS4-2Phase Array 64 elements 2-4MHzC9-4vMicro Curved Linear Array 4-9MHz |
|---|---|
| Measurements | Distance; area; Volume; circumference; Heart Rate; calipers; velocity; PI, RI, Cardiac, OB/GYN and Vascular package. |
| Principle ofOperation | Applying high voltage burst to the Piezoelectric material in the transducer and detect the reflected echo to construct the 2-D B-mode, Doppler color, and Doppler spectrum image for diagnostic purpose. |
| OperatingControls | TGC 8 slider, +/- 22.5 dB Depth Range: 1 to 30 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 100 levels over 20-100 dB Gray Scale Control: 4 Settings Focal Number: 10 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 20 settings, 1% to 20% of PRF PW sample volume: 0.5 to 10mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer key PW angle correction: +/- 72 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 8 preset curve over 15-96 dB Spectrum baseline shift and invert Color ROI setting: Touch and drag to control size and position Color steering on flat probe: +/- 20 Color Wall Filter: Color wall filter with 20 settings, 1% to 20% of PRF Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: Up to 10x Freeze control: Touch freeze key Cine control: step, play backward, play continuously |
| AcousticOutput | Conform to EN60601-2-37 and AIUM UD2/UD3 requirements for all modes of all probes |
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SAFETY CONSIDERATIONS:
InnoSight diagnostic ultrasound has been designed to meet the following voluntary and measurement standards:
| RecognitionNumber | Regulations No./ Version | Recognition Standard |
|---|---|---|
| 12-100 | NEMA UD 3-2004 | Standard for Real Time Display of Thermal andMechanical Acoustic Output Indices on DiagnosticUltrasound Equipment |
| 12-105 | NEMA UD 2-2004 (R2009) | Acoustic Output Measurement Standard forDiagnostic Ultrasound Equipment Revision 3(Radiology) |
| 12-293 | IEC 60601-2-37 Edition 2.1 2015 | Medical electrical equipment - Part 2-37: Particularrequirements for the basic safety and essentialperformance of ultrasonic medical diagnostic andmonitoring equipment |
| 19-4 | AAMI / ANSI ES60601-1:2005/(R)2012And A1:2012,, C1:2009/(R)2012 AndA2:2010/(R)2012 (Consolidated Text) | Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (lec 60601-1:2005, Mod). (General II(ES/EMC)) |
| 19-2 | AAMI / ANSI / IEC60601-1-2:2007/(R)2012 | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 3).(General II (ES/EMC)) |
| 2-220 | ISO 10993-1 Fourth Edition 2009-10-15 | Biological Evaluation Of Medical Devices - Part 1:Evaluation And Testing Within A Risk ManagementProcess [Including: Technical Corrigendum 1 (2010)(Biocompatibility) |
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.