(34 days)
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
The provided 510(k) summary for the SonoSite Edge Ultrasound System (K133454) states that clinical studies were not required to support the determination of substantial equivalence. The submission relies on non-clinical tests and a comparison of technological characteristics to predicate devices.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not explicitly mentioned in the provided text as they would typically stem from a clinical study.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study was performed for this 510(k) submission, there are no specific performance criteria or reported performance results in the context of a clinical evaluation. The document focuses on compliance with established safety standards and equivalence to predicate devices.
The "acceptance criteria" here are implicitly the existing standards and the characteristics of the predicate devices. The "reported device performance" is that it conforms to these standards and shares similar features, functionality, and performance parameters with its predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Electrical safety compliance | Device evaluated for electrical safety and found to conform to applicable mandatory medical device safety standards (e.g., IEC 60601-1, AAMI / ANSI ES60601-1). |
| Thermal safety compliance | Device evaluated for thermal safety and found to conform to applicable mandatory medical device safety standards. |
| Mechanical safety compliance | Device evaluated for mechanical safety and found to conform to applicable mandatory medical device safety standards. |
| EMC safety compliance | Device evaluated for EMC safety and found to conform to applicable mandatory medical device safety standards (e.g., IEC 60601-1-2, CISPR 11, IEC 61000-4 pt 2-5). |
| Cleaning/Disinfection | Device evaluated for cleaning/disinfection procedures. |
| Biocompatibility | All patient contact materials are biocompatible (evaluated per ISO 10993-1). |
| Acoustic output compliance | Acoustic output evaluated and found to conform to applicable mandatory medical device safety standards (e.g., IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004). |
| Quality assurance | Assurance of quality established by employing Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. |
| Overall Equivalence | Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. Device conforms to applicable electromedical device safety standards, shares indications for use, has biosafety equivalence, and is manufactured using the same ISO 13485 quality system as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as no clinical study was performed. The evaluation relied on non-clinical testing and comparison to predicate devices, which implies leveraging existing data and regulatory clearances from those predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable, as no clinical study and associated ground truth establishment for a test set were conducted.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical study was performed.
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, as no clinical study, particularly an MRMC study, comparing AI assistance to human readers was performed. The device described is a general-purpose ultrasound system, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device is a diagnostic ultrasound system, which inherently involves a human operator (qualified physician) for its intended use. It is not an AI algorithm operating autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical study was performed requiring the establishment of ground truth for diagnostic accuracy. For non-clinical aspects like safety and performance, the "ground truth" is adherence to recognized standards and engineering specifications.
8. The sample size for the training set:
Not applicable, as no clinical study was performed, and the device is not described as utilizing a machine learning algorithm that would require a training set of patient data.
9. How the ground truth for the training set was established:
Not applicable, as no clinical study was performed and no machine learning training set is mentioned for the device.
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K133454
Page 1 of 6
510(K) Summary
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter's name, address, telephone number, contact person:
FUJIFILM SonoSite, Inc. 21919 30" Drive SE Bothell, WA 98021-3904
Corresponding Official:
E-mail: Telephone: . Facsimile: Date prepared: Patricia Liau Regulatory Affairs Specialist Patricia.Liau@sonosite.com (425) 951-6870 (425) 951-6713 October 17, 2013
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
SonoSite Edge® Ultrasound System (subject to change)
Classification Names
| Name | 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 |
| Picture Archiving and Communications System | 892.2050 | LLZ |
3) Identification of the predicate or legally marketed device:
| SonoSite Edge Ultrasound System | K113156 |
|---|---|
| SonoSite Maxx Series Ultrasound System | K130173 |
4) Device Description:
The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
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5) Intended Use:
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
- Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
6) Technological Characteristics:
SonoSite Edge and Maxx Series Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.
| Feature | SonoSite EdgeUltrasound System(This Submission) | SonoSite EdgeUltrasound System(K113156) | SonoSite M-Turbo (Maxx Series) UltrasoundSystem(K130173) |
|---|---|---|---|
| Intended Use | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody | Diagnostic ultrasound imaging orfluid flow analysis of the humanbody |
| Indications forUse | OpthalmicFetal - OB/GYNAbdominalIntra-operative (abdominal organsand vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast, thyroid,testicle. prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance | OpthalmicFetal - OB/GYNAbdominalIntra-operative (abdominal organsand vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance | OpthalmicFetal - OB/GYNAbdominalIntra-operative (abdominal organsand vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance |
| TransducerTypes | Linear ArrayCurved Linear ArrayIntracavitaryPhased Array | Linear ArrayCurved Linear ArrayIntracavitaryPhased Array | Linear ArrayCurved Linear ArrayIntracavitaryPhased Array |
| Feature | SonoSite EdgeUltrasound System(This Submission) | SonoSite EdgeUltrasound System(K113156) | SonoSite M-Turbo (MaxxSeries) UltrasoundSystem(K130173) |
| Static Probes | Static Probes | Static Probes | |
| Trans-esophageal | Trans-esophageal | Trans-esophageal | |
| TransducerFrequency | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Global | I spta 3: .709 (TEEX) | I spta 3: .709 (TEEX) | I spta 3: .709 (TEEx) |
| Maximum | TI Type: TIB(P21x)TI Value: 3.7 (P21x) | TI Type: TIB(P21x)TI Value: 3.7 (P21x) | TI Type: TIB(P21x)TI Value: 3.9 (P21x) |
| Outputs/Worst | MI: 1.5 (P21x & L38xi) | MI: 1.5 (P21x & L38xi) | MI: 1.51 (P21x) |
| Case Setting | I pa 3@MI Max: 776 (L38xi) | I pa 3@MI Max: 776 (L38xi) | I pa 3@MI Max: 439.9 (L38x) |
| Acoustic | Display Feature for Higher | Display Feature for Higher | Display Feature for Higher |
| Output Display | OutputsMI Output Display | OutputsMI Output Display | OutputsMI Output Display |
| & FDA Limits | TI Output Display | TI Output Display | TI Output Display |
| Modes of | B-mode Grayscale Imaging | B-mode Grayscale Imaging | B-mode Grayscale Imaging |
| Operation | 3D/4D Grayscale Imaging | ||
| Tissue Harmonic Imaging | Tissue Harmonic Imaging | Tissue Harmonic Imaging | |
| M-mode | M-mode | M-modeAnatomical M-Mode | |
| Color M-Mode | Color M-Mode | Color M-Mode | |
| Color Power Doppler | Color Power Doppler | Color Power Doppler | |
| Zoom | Zoom | Zoom | |
| Combination Modes | Combination Modes | Combination Modes | |
| Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler | Pulsed Wave (PW) Doppler | |
| Continuous Wave (CW) DopplerSonoHD2 Noise Reduction | Continuous Wave (CW) DopplerSonoHD2 Noise Reduction | Continuous Wave (CW) DopplerSonoRes/SonoHD Noise | |
| SonoMB/MBe Image | SonoMB/MBe Image | Reduction | |
| Compounding | Compounding | SonoMB Image Compounding | |
| Steered CW Doppler | Steered CW Doppler | Steered CW Doppler | |
| Velocity Color Doppler | Velocity Color Doppler | Velocity Color Doppler | |
| Color TDI | Color TDI | Color TDI | |
| PW Doppler | Available on all imagingtransducers except D2x/2 MHz. | Available on all imagingtransducers except D2x/2 MHz. | Available on all imagingtransducers except D2x/2 MHz |
| Adjustable sample volume size:1.0 - 25 mm | Adjustable sample volume size:1.0 – 25 mm | Adjustable sample volume size:1.0 - 25 mm | |
| Simultaneous or duplex mode ofoperation | Simultaneous or duplex mode ofoperation | Simultaneous or duplex mode ofoperation | |
| Simultaneous B-mode and PWDoppler | Simultaneous B-mode and PWDoppler | Simultaneous B-mode and PWDoppler | |
| High PRF capability | High PRF capability | High PRF capability | |
| CW Doppler | Available on C11x, D2x/2, P10x,P21x, TEEx | Available on C11x, D2x/2, P10x,P21x, TEEx | Available on C11x, D2x/2, P10x,P17x, P21x, TEEx |
| Simultaneous or duplex mode ofoperation | Simultaneous or duplex mode ofoperation | Simultaneous or duplex mode ofoperation | |
| Simultaneous B-mode and CWDoppler | Simultaneous B-mode and CWDoppler | Simultaneous B-mode and CWDoppler | |
| Velocity Color | Available on all transducersexcept D2x/2 | Available on all transducersexcept D2x/2 | Available on all transducersexcept D2x/2 |
| Doppler | |||
| Elastography(Strain), and | Available on all transducersexcept D2x/2 | Available on all transducersexcept D2x/2 | Available on all transducersexcept D2x/2 |
| Strain Rate | |||
| Imaging | |||
| ECG Feature | One 3-lead ECG input, orOne external ECG input, or | One 3-lead ECG input, orOne external ECG input, or | One 3-lead ECG input, orOne external ECG input, or |
| One other physio input | One other physio input | One other physio input | |
| DICOM | DICOM 3.0 CStore, Print, andModality Worklist service class | DICOM 3.0 CStore, Print, andModality Worklist service class | DICOM 3.0 CStore, Print, andModality Worklist service class |
| user features | user features. | user features. |
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| Feature | SonoSite EdgeUltrasound System(This Submission) | SonoSite EdgeUltrasound System(K113156) | SonoSite M-Turbo (MaxxSeries) UltrasoundSystem(K130173) | |||
|---|---|---|---|---|---|---|
| IMT | SonoCalc IMT provides the | SonoCalc IMT provides the | SonoCalc IMT provides the | |||
| capability for automated | capability for automated | capability for automated | ||||
| Measurement | measurement of intima-media | measurement of intima-media | measurement of intima-media | |||
| thickness (IMT) of the carotid | thickness (IMT) of the carotid | thickness (IMT) of the carotid | ||||
| artery. IMT functionality is | artery. IMT functionality is | artery. IMT functionality is | ||||
| available both on the ultrasound | available both on the ultrasound | available both on the ultrasound | ||||
| system and in a stand alone | system and in a stand alone | system and in a stand alone | ||||
| software program that runs on a | software program that runs on a | software program that runs on a | ||||
| personal computer. | personal computer. | personal computer. | ||||
| 128 digital channels | 128 digital channels | 128 digital channels | ||||
| #TransmitChannels | ||||||
| #Receive | 128 digital channels (using SA) | 128 digital channels (using SA) | 128 digital channels (using SA) | |||
| Channels | ||||||
| Patient | Transducers: | Transducers: | Transducers: | |||
| Contact | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | |||
| Materials | (ABS) | (ABS) | (ABS) | |||
| Cycoloy | Cycoloy | Cycoloy | ||||
| Dow Medical Adhesive, Type A | Dow Medical Adhesive, Type A | Dow Medical Adhesive, Type A | ||||
| Epoxy paste adhesive, | Epoxy paste adhesive. | Epoxy paste adhesive. | ||||
| Polysulfone UDEL P1700 | Polysulfone UDEL P1700 | Polysulfone UDEL P1700 | ||||
| Polyurethane | Polyurethane | Polyurethane | ||||
| Poly-Vinyl-Chloride (PVC) | Poly-Vinyl-Chloride (PVC) | Poly-Vinyl-Chloride (PVC) | ||||
| Silicone Rubber | Silicone Rubber | Silicone Rubber | ||||
| Urethane | Urethane | Urethane | ||||
| Needle Guides: | Needle Guides: | Needle Guides: | ||||
| Acetal copolymer | Acetal copolymer | Acetal copolymer | ||||
| Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | Acrylonitrile-butadien-styrene | ||||
| (ABS) | (ABS) | (ABS) | ||||
| CAN/CSA C22.2 No. 601.1 | CAN/CSA C22.2 No. 601.1 | CAN/CSA C22.2 No. 601.1 | ||||
| Product Safety | EN 60601-1 | EN 60601-1 | EN 60601-1 | |||
| Certification | EN 60601-1-1 | EN 60601-1-1 | EN 60601-1-1 | |||
| UL 60601-1 | UL 60601-1 | UL 60601-1 | ||||
| JIS T 0601-1, JIS T 1507 | JIS T 0601-1, JIS T 1507 | JIS T 0601-1, JIS T 1507 | ||||
| CEI/IEC 61157 | CEI/IEC 61157 | CEI/IEC 61157 | ||||
| ANSI/AAMI EC53 | ANSI/AAMI EC53 | ANSI/AAMI EC53 | ||||
| EMC | EN 60601-1-2:2007 | EN 60601-1-2:2007 | EN 60601-1-2:2007 | |||
| Compliance | CISPR 11 | CISPR 11 | CISPR 11 | |||
| IEC 61000-4 pt 2-5 | IEC 61000-4 pt 2-5 | IEC 61000-4 pt 2-5 | ||||
| DICOM | NEMA PS3.15 2003 | NEMA PS3.15 2003 | NEMA PS3.15 2003 | |||
| Airborne | RTCA/DO160D (section 21) | RTCA/DO160D (section 21) | RTCA/DO160D (section 21) | |||
| Equipment | ||||||
| Standards | ||||||
| System | Edge: | Edge: | M Series: | |||
| Characteristics | Beamformer 128/128 using SA | Beamformer 128/128 using SA | Beamformer 128/128 using SA | |||
| (configurable) | (configurable) | (configurable) | ||||
| Hand held display and control | Hand held display and control | Hand held display and control | ||||
| Single 12.1" Liquid Crystal Display | Single 12.1" Liquid Crystal Display | Single 10.4" Liquid Crystal Display | ||||
| (LCD)256 gray shades on LCD | (LCD)256 gray shades on LCD | (LCD)256 gray shades on LCD | ||||
| Dimensions: 12.9"(W) x 12.4 (L) x | Dimensions: 12.9"(W) x 12.4 (L) x | Dimensions: 10.9"(W) x 11.8 (L) x | ||||
| 2.5"(H) | 2.5"(H) | 3.0"(H) | ||||
| Weight: 8.5 lbs | Weight: 8.5 lbs | Weight: 8.3 lbs | ||||
| Battery operated (1.5 - 4 hour | Battery operated (1.5 - 4 hour | Battery operated (1.5 - 4 hour | ||||
| operation per charge) | operation per charge) | operation per charge) | operation per charge) | operation per charge) | operation per charge) |
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| SonoSite Edge | SonoSite Edge | SonoSite M-Turbo (Maxx | |
|---|---|---|---|
| Ultrasound System | Ultrasound System | Series) Ultrasound | |
| Feature | (This Submission) | (K113156) | System |
| (K130173) | |||
| 100 - 240V options, 50/60 Hz,15VDC output | 100 - 240V options, 50/60 Hz,15VDC output | 100 - 240V options, 50/60 Hz | |
| Various obstetrical, cardiac, | |||
| Various obstetrical, cardiac.volume, M-mode, PW and CW | Various obstetrical, cardiac,volume, M-mode, PW and CW | volume, M-mode, PW and CWDoppier measurement and | |
| Doppler measurement andcalculation packages | Doppler measurement andcalculation packages | calculation packages | |
| ECG acquisition and display | |||
| ECG acquisition and displaycapabilities | ECG acquisition and displaycapabilities | capabilitiesCW/PW Doppler Audio | |
| CW/PW Doppler Audio | CWIPW Doppler Audio | Spectral Doppler Audio and image | |
| Spectral Doppler Audio and image | Spectral Doppler Audio and image | storage on removable media | |
| storage on removable media | storage on removable media | Measurement on Recalledlmages. | |
| Wireless 802 11 (a\b\g) support forimage transfer | Wireless 802.11 (a\b\g) support forimage transfer | Wireless 802.11 {a\b\q} support forimage transfer and Bluetooth® 20.for voice activated remote control. | |
| S Series: | |||
| Beamformer 128/128 using SA | |||
| (configurable)Hand held display and control | |||
| Single 10.4" Liquid Crystal Display | |||
| (LCD)256 gray shades on LCD | |||
| Dimensions: 11.5"(W) x 14.8 (L) x2.8"(H) | |||
| Weight: 8.5 Ibs | |||
| Battery operated (1.5 - 4 houroperation per charge) | |||
| 100 - 240V options, 50/60 Hz | |||
| Various obstetrical, cardiac. | |||
| volume, and M-modemeasurement and calculation | |||
| packages | |||
| ECG acquisition and display | |||
| capabilitiesImage storage on removable | |||
| media | |||
| Measurement on recalled images | |||
| Wireless 802.11 {a\b\g} support for | |||
| image transfer and Bluetooth® 2.0for voice activated remote control | |||
| 510(k) Track | Track 3 | Track 3 | Track 3 |
{5}------------------------------------------------
7) Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The SonoSite Edge Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to all applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. All patient contact materials are biocompatible. Reports for these elements of product development are referenced in Attachment 6.
| Reference No. | Title | ||||||
|---|---|---|---|---|---|---|---|
| AAMI/ANSI/ISO 10993-1 | ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation andtesting within a risk management process | ||||||
| IEC 60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | ||||||
| IEC 60601-1-2 | IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateral standard: Electromagneticcompatibility - Requirements and tests (Edition 3) | ||||||
| IEC 60601-2-37 | IEC 60601-2-37:2007, Particular Requirements for the basic safety and essentialperformance of ultrasonic medical diagnostic and monitoring equipment | ||||||
| ISO 14971 | ISO 14971: 2007, Medical devices - Application of risk management to medical |
The Edge Ultrasound System is designed to comply with the following voluntary standards.
NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD 3-2004 Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine NEMA PS 3.15 NEMA Ps 3.15.2011, Digital Imaging and Communications in Medicine (DICOM), Part 15: Security and System Management Profiles
Summary of Clinical Tests:
devices
The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence.
Conclusion: 8)
Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The Edge and predicate device both conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The Edge and predicate device both meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and are manufactured using the same ISO 13485 quality system. FUJIFILM SonoSite, Inc. believes that the Edge Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate device.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is oriented to follow the curve of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2013
FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K133454
Trade/Device Name: Sonosite Edge® Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 11, 2013 Received: November 12, 2013
Dear Mr. Job:
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 intended for use with the Edge® Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| C8x/8-5 MHz | C11x/8-5 MHz | D2x/2 MHz |
|---|---|---|
| C60x/5-2 MHz | HFL38x/13-6 MHz | HFL50x/15-6 MHz |
| ICTx/8-5 MHz | L25x/13-6 MHz | L38xi/10-5 MHz |
| L38x/10-5 MHz | P10x/8-4 MHz | P11x/10-5 MHz |
| P21x/5-1 MHz | SLAx/13-6 MHz | TEEX/8-3 MHz |
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
{7}------------------------------------------------
Page 2-Mr. Job
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 a
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You mav 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.htm.
Sincerely yours,
Smh)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) TBD K133454
Device Name
SonoSite Edge Ultrasound System
Indications for Use (Describe)
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
Type of Use (Select one or both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
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)
Page 8 of 30
{9}------------------------------------------------
Table 1.3-1 Diagnostic Ultrasound Indications for Use Form – FUJIFILM SonoSite Edge Ultrasound System
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Fetal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Abdominal | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 |
| Intra-operative (Abdominalorgans and vascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Neuro.)Laparoscopic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| PediatricSmall Organ (breast, thyroid,testicles, prostate) | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 |
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Adult Cephalic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Trans-rectal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Trans-vaginal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.)Other (spec.) | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 |
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
| Transducer: | C8x/8-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of | ||||||
| the human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles, prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Trans-vaginal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Additional Comments :-
All items marked "P" were previously cleared in 510(k) K113156.
ﺍﻟﻤﻮﺍﺻﻞ ﺍﻟﻤﺮﺍﺣﻞ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﺴﻮﺍﺭﻱ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﺴﻴﺎﺳﻲ ﺍﻟﻤﺘﻮﺳﻂ. ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟ
{10}------------------------------------------------
Table 1.3-2 Diagnostic Ultrasound Indications for Use Form - C8x/8-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMBIMBe compund imaging itsue Dopler imaging (TD), inacing to guidance of biopsy and in the placement of needes and cathers in
vascular or other anatomical structures Color Dopler Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134 and K082098.
Prescription Use (Per 21 CFR 801.109)
Page 3 of 17
Page 10 of 30
{11}------------------------------------------------
Table 1.3-3 Diagnostic Ultrasound Indications for Use Form - C11x/8-5 Transducer
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C11x/8-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD:B+CWD; B+CD | Note 1 | |
| Intra-operative (Abdominal organs andvascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 |
| Small Organ (breast, thyroid, testicles. prostate) | B+M; B+PWD:B+CD | Note 1 | |||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Other (spec.) |
N= new indication: P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1 · Other includes color power Doppier, combined B and color power Doppler, issue harmonic imaging, SonoMBIMBe compound imaging, issue Doppler imaging (TDI), imaging guidance for penpheral herve block procedures, imaging to assist in the placement of needles and cather andomical stuctures. Color Doppler includes velocity color Dopler. Color
Dopler can be combined with any imaging mode. M-Mo
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
Page 4 of 17
{12}------------------------------------------------
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | D2x/2 MHz Dual Element Circular Array | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles, prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | ||||||
| Cardiac Pediatric | P | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 1.3-4 Diagnostic Ultrasound Indications for Use Form – D2x/2 Transducer
N= new indication: P= previously cleared by FDA; E= added under this appendix
Additional Comments:
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
Page 5 of 17
the first and the comments of the comments of the comments of the comments of the comments of the comments of the section of the section of the section of the section of the
{13}------------------------------------------------
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C60x/5-2 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Abdominal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Other (spec.) |
Table 1.3-5 Diagnostic Ultrasound Indications for Use Form – C60x/5-2 Transducer
Additional Comments:
Note 1: Other includes color power Dopler, combined B and color power Doppler, iissue harmonic imaging, SonoHD2 imaging, SonoMBIMBe room in may also potor inaging to block on por por and include maging, sondro condegrine commender
compund imaging (TD), maging bidane in period neve block groenent of spins anatomical structures. Color Doppler includes velocity color Doppler can be combined with any imaging mode. M-Made includes color M-Mode.
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Boor Taller France of the
All items marked "P" were previously cleared in 510(k) K071134.
{14}------------------------------------------------
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | HFL38x/13-6 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles, prostate) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Other (spec.) |
Table 1.3-6 Diagnostic Ultrasound Indications for Use Form -- HFL38x/13-6 Transducer
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMBAMBe compund imaging tissue Dopler imaging (TD), imaging guideral nerve block procedures, imaging of spinal cord to povide guidence in vascular or the anatomical structures. Calor Doppler includes velocity color Doppier can be combined with any imaging mode. M-Mote includes cator M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
ﻤﺴﻴﻨﻴﻨﻴﺔ
{15}------------------------------------------------
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | HFL50x/15-6 MHz Transducer | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| B+M; B+PWD; | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Other (spec.) |
Table 1.3-7 Diagnostic Ultrasound Indications for Use Form - HFL50x/15-6 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
ﻠﻴﻨﺖ ﺍﻟﻤﺴﺎ
Additional Comments:
Note 1: Other includes color power Doppler, combined B and cotor power Doptler, tissue harmonic imaging, SonoHD2 imaging, SonoMBIMBe compound imaging, tissue Doppler imaging gurdance for perioheral neve block procedures, imaging of spinal cord to provide guidance for central nerve block procedures, imaging to guidance of biopsy and imaging to assist in the placement of needler or other anatomical structures. Color Doppler includes velocity color Doppler can be combined with any maging mode. M-Mode includes color M-Mode.
and a wall and the most of the resear
ﺘﻌﺪﺩ ﺍﻟﻤﻌﻠﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
and the same of the same of the same of the states of the same of the same of the
{16}------------------------------------------------
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | ICTx/8-5 MHz Transducer | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of | ||||||||
| the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |||
| Abdominal | |||||||||
| Intra-operative (Abdominal organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |||
| Trans-vaginal | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | |||||||||
| Other (spec.) |
Table 1.3-8 Diagnostic Ultrasound Indications for Use Form -- ICTx/8-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, lissue harmonic imaging, SonoMBMBe compound imaging (TD). imaging (TDI). imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in offically in and copper magnig roy, magnig of gudance of bippy and minghis in the concerner of recors and cambres model.
vasular or the analomical stuctures. Coor Dopler in
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
Page 9 of 17
SALE LA LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE L
Page 16 of 30
{17}------------------------------------------------
Table 1.3-9 Diagnostic Ultrasound Indications for Use Form - L25x/13-6 Transducer
| System: | FUJIFILM SonoSite Edge Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L25x/13-6 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| Ophthalmic | P | P | P | B+M; B+CD | Note 1 | |||
| Fetal | ||||||||
| Abdominal | P | P | P | B+M; B+CD | Note 1 | |||
| Intra-operative (Abdominal organs andvascular) | P | P | P | B+M; B+CD | Note 1 | |||
| Intra-operative (Neuro.)Laparoscopic | ||||||||
| Pediatric | P | P | P | B+M; B+CWD;B+CD | Note 1 | |||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | B+M; B+CD | Note 1 | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+CD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+CD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | B+M; B+CD | Note 1 | |||
| Other (spec.) |
Additional Comments:
Not 1: Ohe includes colo contined and color power Doper, issue harmoni, maging, Sondh24.
compund inaging tissue Dopler imaging golderes incontent inaging in guidance di cingi Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134 and K082098.
Prescription Use (Per 21 CFR 801,109)
ﻀﻤﻨﺸ
Page 10 of 17
Page 17 of 30
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ﺘﺤﻘﻪ
==============================================================================================================================================================================
{18}------------------------------------------------
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | L38xi/10-5 MHz Transducer | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of | ||||||||
| the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Intra-luminal | |||||||||
| Other (spec:) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac PediatricTrans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Other (spec.) |
Table 1.3-10 Diagnostic Ultrasound Indications for Use Form - L38xi/10-5 Transducer
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, iissue harmonic imaging, SonoHB/MB compound inaging, tissue Doppler imaging (TDI), imaging guidance for periores imaging of spinal cord to provide guidance for central nerve block procedures, imaging to gird inaging to assist in the placement of needles and cathers in vascular or other anatomical structures. Color Doppler includes velocity color Dopler can be combined with any imaging mode. M-Mode includes color M-Mode.
and and the state of the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the state of the
All items marked "P" were previously cleared in 510(k) K113156.
{19}------------------------------------------------
| Table 1.3-11 Diagnostic Ultrasound Indications for Use Form - L38x/10-5 | ||
|---|---|---|
| Transducer |
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | L38x/10-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of | ||||||
| the human body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Other (spec.) |
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoHD2 imaging, SonoMBIMBe compound imaging, tissue Doppler imaging (TD)), imaging guidance for perinteral neve block procedures, imaging of spinal cord to provide guidance lor central neve block proceded to bopsy and integing to assis in the placement on needes and cathers in rascular or che M-Mode.
and and the same and think and the compress of the final comments and instruments of the while while would
All items marked "P" were previously cleared in 510(k) K071134.
all differentle to the block the election in the block and the block and and comments of the seat of the
{20}------------------------------------------------
Table 1.3-12 Diagnostic Ultrasound Indications for Use Form - P10x/8-4 Transducer
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P10x/8-4 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWDB+CD | Note 1 | |
| Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWDB+CD | Note 1 | |
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWDB+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWDB+CD | Note 1 | |
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD ,B+CD | Note 1 | |
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWDB+CD | Note 1 | |
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD:B+CD | Note 1 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMB/MBe compound imaging, tissue Doppler imaging (TDI, imaging guidance for perioheral nerve block procedures, imaging for guidance of biopsy and imaging to assist in the placement of needler or vascular or other anatomical structures. Color Doppler includes velocity color and maging to assist in the placement of neceise in vasular of the mindinical shortined shortheres. Ook Door and mich
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
Page 13 of 17
{21}------------------------------------------------
Table 1.3-13 Diagnostic Ultrasound Indications for Use Form - P11x/10-5 Transducer
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P11x/10-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organsand vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | B+M; B+CD | Note 1 | ||
| Small Organ (breast, thyroid,testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | B+M; B+CD | Note 1 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1: Other includes color power Dopler, combined B and color power Dopler, M-Mode, SonoHD2 imaging, SonoMBMBe compound imaging, wou'r. Online middles color popler, comained in model popier and inaging to assist in the placement of needes and catheters in vascular or other anatomical structures. Color Dopler can be combined with any imaging mode. Can be used with disposable kit cleared with K113680.
All items marked "P" were previously cleared in 510(k) K130173.
{22}------------------------------------------------
Table 1.3-14 Diagnostic Ultrasound Indications for Use Form – P21x/5-1 Transducer
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P21x/5-1 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Fetal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 |
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
Additional Comments:
Note 1; Other includes color power Doppier, combined B and color power Doppler, tissue harmonic imaging, SonoMBIMBe compound imaging tissue Doppler imaging (TDI), color TDI, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures. Color Dopter includes velocity color Doppler can be combined with any imaging mode M-Mode includes color M-Mode .___________________________________________________________________________________________________________________________________________ ﻟﺘﻘﺪﻳﻤﺔ ﺍﻟﻤﺴﺎ 174 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 ------------
All items marked "P" were previously cleared in 510(k) K071134.
{23}------------------------------------------------
Table 1.3-15 Diagnostic Ultrasound Indications for Use Form - SLAx/13-6 Transducer
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | SLAx/13-6 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | P | P | P | P | B+M; B+PWD:B+CD | Note 1 | |
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |
| Other (spec.) |
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoHD2 imaging, SonoMBMBe Noter in the minder collection on over por respect note hights in only of in an anyag condines
compuni maging listic magins con contribus no sections . incoln on guidance .
11 - 15 - 12 - 12 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -
All items marked "P" were previously cleared in 510(k) K071134 and K082098. 『
{24}------------------------------------------------
Table 1.3-16 Diagnostic Ultrasound Indications for Use Form – TEEx/8-3 Transducer
| System: | FUJIFILM SonoSite Edge Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | TEEx/8-3 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis ofthe human body as follows: | ||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 |
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
to any the this with a string world resident in all street and state and
Additional Comments:
Note 1: Qther includes color power Doppler, combined B and color power Doppler, tissue harmonic imaging, SonoMBIMBe compound imaging, tissue Doppler imaging (TDI, color TDI, imaging to guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other analorical structures. Color Doppler. Color Dopler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
13 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
And The Bank States
Page 17 of 17 Page 24 of 30
§ 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.