(29 days)
The Vivid T8/Vivid T8 Pro is Multipurpose Cardiovascular System designed for cardiac and Shared Service Imaging, the system supports following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Musculoskeletal Superficial/Conventional, Adult Cephalic, Neonatal Cephalic, Transcranial, Transrectal, Transvaginal and Transesophageal.
The Vivid T8/Vivid T8 Pro is the full featured general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel.
The GE Healthcare Vivid T8/T8 Pro is a diagnostic ultrasound system. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on establishing "substantial equivalence" of the Vivid T8/T8 Pro to predicate devices (K121063 GE Vivid S6/S5 BT12 and K133034 GE LOGIQ F Series). The acceptance criteria are implicitly defined by the safety and performance characteristics of these predicate devices. The study demonstrates that the Vivid T8/T8 Pro meets these implied criteria, meaning it performs comparably to the predicate devices and thus is considered safe and effective.
The provided document does not contain a specific table of quantitative acceptance criteria for image quality or clinical performance that would typically be found for an AI/CADe device. Instead, the "performance" is demonstrated through conformity to relevant medical device safety and performance standards, and comparison of features and intended use with the predicate devices.
Summary of Device Performance (based on provided text):
The Vivid T8/Vivid T8 Pro is reported to be substantially equivalent to the predicate devices regarding:
- Intended Use and Clinical Applications.
- Imaging Capabilities (Image modes: B; M; Color, Power, PW & CW Doppler modes, Color M-mode, Harmonic imaging, Combined modes).
- Technological Characteristics.
- Safety and Effectiveness.
It also conforms to the following voluntary standards:
- AAMI/ANSI ES60601-1 (Medical Electrical Equipment - Part 1 : General Requirements for Safety)
- IEC60601-1-2 (Electromagnetic Compatibility Requirements and Tests)
- IEC60601-2-37 (Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)
- NEMA UD 3 (Thermal and Mechanical Acoustic Output Indices)
- ISO10993-1 (Biological Evaluation of Medical Devices)
- NEMA UD 2 (Acoustic Output Measurement Standard)
- ISO14971 (Application of risk management to medical devices)
- NEMA, DICOM Set (Digital Imaging and Communications in Medicine)
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "The subject of this premarket submission, Vivid T8/Vivid T8 Pro, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set or associated data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical tests and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no clinical studies were performed, there was no test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was done, as explicitly stated that no clinical studies were required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The submission is for a diagnostic ultrasound system, which is a medical imaging device operated by a human. It is not an AI algorithm or CADe device, so the concept of standalone algorithm performance is not applicable in this context. The device's performance is inherently human-in-the-loop.
7. The Type of Ground Truth Used
Not applicable, as no clinical studies were performed. The "ground truth" for this submission relies on established safety and performance standards for diagnostic ultrasound systems and the performance characteristics of predicate devices.
8. The Sample Size for the Training Set
Not applicable. The Vivid T8/T8 Pro is a traditional ultrasound system, not an AI/Machine Learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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Image /page/0/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.
K141067
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | April 22, 2014 |
| Submitter: | GE Healthcare9900 Innovation DrWauwatosa, WI 53226 |
| Primary Contact Person: | Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275 |
| Secondary Contact Person: | Jiawei ZHANGRegulatory AffairsGE HealthcareT: +86 510 8527 8259F: +86 510 8522 7347 |
| Device: Trade Name: | Vivid T8, Vivid T8 Pro |
| Common/Usual Name: | Vivid T8, Vivid T8 Pro |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX |
| Predicate Device(s): | K121063 GE Vivid S6/S5 BT12K133034 GE LOGIQ F Series |
| Device Description: | The Vivid T8/Vivid T8 Pro is the full featured general purposediagnostic ultrasound system which consists of a mobile consolethat provides digital acquisition, processing and displaycapability. The user interface includes a computer keyboard,color LCD image display and touch panel |
| Intended Use: | Vivid T8/Vivid T8 Pro is Multipurpose Cardiovascular Systemdesigned for cardiac and Shared Service Imaging, the systemsupports following applications: Fetal/OB, Abdominal, Pediatric,Small Organ, Cardiac, Peripheral Vascular, MusculoskeletalSuperficial/Conventional, Adult Cephalic, Neonatal Cephalic,Transcranial, Transrectal, Transvaginal and Transesophageal |
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are solid black, creating a high-contrast image.
GE Healthcare 510(k) Premarket Notification Submission
Vivid T8/Vivid T8 Pro employs the same fundamental scientific Technology: technology as its predicate devices.
Comparison to Predicate Devices
Determination of Substantial Equivalence:
The Vivid T8 and T8 Pro systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
| Proposed DeviceVivid T8/VividT8 Pro | Predicate DeviceVivid S5/S6(K121063) | ||
|---|---|---|---|
| Indications and Clinical Applications: | |||
| • | Fetal/Obstetrics; | ✓ | ✓ |
| • | Abdominal/GYNPediatric; | ✓ | ✓ |
| • | Small Organ (breast, testes,thyroid); | ✓ | ✓ |
| • | Neonatal Cephalic; | ✓ | ✓ |
| • | Adult Cephalic; | ✓ | ✓ |
| • | Cardiac (adult andpediatric); | ✓ | ✓ |
| • | Peripheral Vascular; | ✓ | ✓ |
| • | Musculo-skeletalConventional andSuperficial; | ✓ | ✓ |
| • | Urology (includingprostate); | ✓ | ✓ |
| • | Transesophageal; | ✓ | ✓ |
| • | Transrectal; | ✓ | ✓ |
| • | Transvaginal; | ✓ | ✓ |
| • | Intraoperative (abdominal,thoracic, and vascular). | ✓ | |
| Contact Type | |||
| • | Surface, Cavitary , TEE | ✓ | ✓ |
| Image modes: | |||
| • | B; M; Color, Power,PW& CW Doppler modes,Color M-mode, Harmonicimaging, Combined modes | ✓ | ✓ |
| Transducers | |||
| • | 3S-RS | ✓ | |
| • | 5S-RS | ✓ | |
| • | 6S-RS | ✓ | ✓ |
| • | 7S-RS | ✓ | |
| • | 10S-RS | ✓ | |
| • | M4S-RS | ✓ |
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circle. There are decorative swirls or flourishes around the circle, adding to the logo's design.
510(k) Premarket Notification Submission
| • | 4C-RS | ✓ | ✓ |
|---|---|---|---|
| • | 8C-RS | ✓ | ✓ |
| • | E8C-RS | ✓ | ✓ |
| • | 8L-RS | ✓ | |
| • | 9L-RS | ✓ | |
| • | 12L-RS | ✓ | |
| • | i12L-RS | ✓ | |
| • | 6Tc / 6Tc-RS | ✓ | ✓ |
| • | 6T / 6T-RS | ✓ | |
| • | 9T / 9T-RS | ✓ | |
| • | P2D | ✓ | |
| • | P6D | ✓ | |
| • | 3Sc-RS | ✓ | ✓ |
| • | 12S-RS | ✓ | |
| • | L6-12-RS | (same transduceras that on thepredicate LOGIQF SeriesK133034) | |
| Processing & Display features: | |||
| • | Image freeze,Multipleimages, Pan/Zoom, Image maps (color& gray), Cine loop, Spatial& temporal filters, L-R / T-B image rev., LVOContrast, Digitalharmonics, TGC, Raw dataaccess, ATO/ASO,Compound Imaging,Speckle Reduction, B-Flow, Blood FlowImaging, TSI, TVI/TT,SI/SRI Stress, LOGIQView, Automated FunctionImaging (AFI), AutoEF,CPI (coded phaseinversion) | ✓ | ✓ |
| • | Smart; Depth with syntheticaperture, Clear Vessel,Continuous Tissue;Optimization (CTO),Tissue CharacteristicOptimization (TCO) | ✓ | |
| Tested to meet ElectricalSafety, EMC andBiocompatibility Standards | ✓ | ✓ | |
| Track 3 (within FDAlimits) | ✓ | ✓ |
510(k) Premarket Notification Submission
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GE Healthcare 510(k) Premarket Notification Submission
Summary of Non-Clinical Tests:
Vivid T8/Vivid T8 Pro has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to conform with applicable medical device safety standards. The Vivid T8/Vivid T8 Pro complies with voluntary standards:
-
- AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1 : General Requirements for Safety
-
- IEC60601-1-2, Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
-
- IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
-
- NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
-
- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
-
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
-
- ISO14971, Application of risk management to medical devices
-
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures are applied to the development of the system:
- . Risk Analysis
- . Requirements Reviews
- Design Reviews .
- . Testing on unit level (Module verification)
- Integration testing (System verification) .
- Performance testing (Verification) .
- Safety testing (Verification) .
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be in a cursive font. The logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission
- Simulated use testing (Validation) .
Transducer material and other patient contact materials such as needle guidance kits are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Vivid T8/Vivid T8 Pro, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Vivid T8/Vivid T8 Pro to be as safe, Conclusion: as effective, and performance is substantially equivalent to the predicate device(s).
Conclusion:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2014
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K141067
Trade/Device Name: Vivid T8, Vivid T8 Pro Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 22, 2014 Received: April 24, 2014
Dear Mr. Behn:
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 Vivid T8 and Vivid T8 Pro Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 4C-RS | E8C-RS |
|---|---|
| 3Sc-RS | L6-12-RS |
| 8C-RS | P2D |
| 6S-RS | 6Tc-RS |
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.
{6}------------------------------------------------
Page 2-Mr. Behn
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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Smh.7)
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) K141067
Device Name
Vivid T8/Vivid T8 Pro Diagnostic Ultrasound System
Indications for Use (Describe)
The Vivid T8/Vivid T8 Pro is Multipurpose Cardiovascular System designed for cardiac and Shared Service Imaging, the system supports following applications: Fetal/OB. Abdominal. Pediatric. Small Organ. Cardiac. Vascular. Adult Cephalic, Neonatal Cephalic, Musculoskeletal Superticial/Conventional, Transrectal, Transvaginal and Transesophageal.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No, 0910-0120
Explration Date: January 31, 2017
See PRA Statement below.
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)
Sm.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
15
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Diagnostic Ultrasound Indications for Use Form
Vivid T8/Vivid T8 Pro Ultrasound System
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | Combined | Harmonic | Coded | ||||||
| Anatomy/Region of Interest | PW | CW | Color | ColorM | Power | Modes | Imaging | Pulse | Other | ||
| Ophthalmic | N | N | N | N | N | N | N | N | N | N | N |
| Fetal/OB | N | N | N | N | N | N | N | N | N | N | N |
| Abdominal1 | N | N | N | N | N | N | N | N | N | N | N |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N |
| Small Organ (specify)(2) | N | N | N | N | N | N | N | N | N | N | N |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | N |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | N |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | N |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | N |
| Thoracic/Pleural (specify) | N | N | N | N | N | N | N | N | N | N | N |
| Other (specify) | N | N | N | N | N | N | N | N | N | N | N |
| Exam Type, Means of Access | |||||||||||
| Transcranial | N | N | N | N | N | N | N | N | N | N | N |
| Transorbital | N | N | N | N | N | N | N | N | N | N | N |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | N |
| Transrectal | N | N | N | N | N | N | N | N | N | N | N |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | N |
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| Laparoscopic |
[I] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are color/power Doppler with B-mode
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 2 of. I 0
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Diagnostic Ultrasound Indications for Use Form
Vivid T8/Vivid T8 Pro with 4C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | CombinedModes* | HarmonicImaging | CodedPulse | Other | |||||
| Anatomy/Region of Interest | PW | CW | Color | ColorM | Power | ||||||
| Ophthalmic | P | P | P | P | P | P | P | P | P | ||
| Fetal/OB | P | P | P | P | P | P | P | P | P | ||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | ||
| Pediatric | P | P | P | P | P | P | P | P | P | ||
| Small Organ (specify)[2] | P | P | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (KI21063)
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid:
[3] Cardiac is Adult and Pediatric:
[1] Caralac is Addin and Pocial.right M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE UN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 3 of 10
{10}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form Vivid T8/Vivid T8 Pro with E8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Doppler Modes | |||||||||||
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | Combined Harmonic Modes | Harmonic Imaging | Coded Pulse | Other |
| Ophthalmic | |||||||||||
| Fetal/OB | P | P | P | P | P | P | P | P | P | ||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | ||
| Pediatric | |||||||||||
| Small Organ (specify)[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | P | P | P | P | P | P | ||
| Transvaginal | P | P | P | P | P | P | P | P | P | ||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K121063)
[I] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, and thyroid
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 4 of 10
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Diagnostic Ultrasound Indications for Use Form Vivid T8/Vivid T8 Pro with 3Sc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical ApplicationAnatomy/Region of Interest | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | CombinedModes | HarmonicImaging | CodedPulse | Other | ||||||
| PW | CW | Color | ColorM | Power | ||||||||
| Ophthalmic | ||||||||||||
| Fetal/OB | ||||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Small Organ (specify)[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Thoracic/Pleural (specify) | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | N | N | N | N | N | N | N | N | N | N | ||
| Transorbital | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular/Intraluminal | ||||||||||||
| Intracardiac | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K121063)
[I] Abdominal includes GYN and Urological Notes:
[2] Small Organ includes breast, testes, and thyroid
[3] Cardiac is Adult and Pediatric
*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 5 of 10
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Diagnostic Ultrasound Indications for Use Form Vivid T8/Vivid T8 Pro with L6-12-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | PW | CW | Color | ColorM | Power | CombinedModes | HarmonicImaging | CodedPulse | Other |
| Ophthalmic | |||||||||||
| Fetal/OB | |||||||||||
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | N |
| Pediatric | P | N | P | P | P | N | P | P | P | N | |
| Small Organ (specify)[2] | P | N | P | P | P | N | P | P | P | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | N | P | P | P | N | P | P | P | N | |
| Musculo-skeletal Conventional | P | N | P | P | P | N | P | P | P | N | |
| Musculo-skeletal Superficial | P | N | P | P | P | N | P | P | P | N | |
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K133034)
[ I ] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
(* ) Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IP NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radlological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 6 of 10
{13}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Vivid T8/Vivid T8 Pro with 8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical ApplicationAnatomy/Region of Interest | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | CombinedModes | HarmonicImaging | CodedPulse | Other | |||||
| PW | CW | Color | ColorM | Power | |||||||
| Ophthalmic | |||||||||||
| Fetal/OB | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | ||
| Small Organ (specify)[2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | ||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K121063)
[1] Abdominal includes GYN and Urological: Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD. B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 7 of !0
{14}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form Vivid T8/Vivid T8 Pro with P2D Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | Doppler Modes | CombinedModes | HarmonicImaging | CodedPulse | Other | ||||
| PW | CW | Color | ColorM | Power | |||||||
| Ophthalmic | |||||||||||
| Fetal/OB | |||||||||||
| Abdominal(1) | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify)[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | P | ||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| l aparoscopic |
N = new indication; P = previously cleared by FDA (K121063)
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric:
[3] Calulac is Adult and Pealants.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
. Page 8 of 10
{15}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form Vivid T8/Vivid T8 Pro with 6S-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | PW | CW | Doppler ModesColor | ColorM | Power | CombinedModes | HarmonicImaging | CodedPulse | Other |
| Ophthalmic | |||||||||||
| Fetal/OB | P | P | P | P | P | P | P | P | P | P | |
| Abdominal(1) | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ (specify)(2) | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | |||||||||||
| Cardiac(3) | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| โ จทลากระดดเต |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric:
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IP NEEDED)
Concurrence of CDRH, Office of In Vitro Dlagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 9 of 10
{16}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form Vivid T8/Vivid T8 Pro with 6Tc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | Combined Harmonic | Coded | |||||||
| Anatomy/Region of Interest | PW | CW | Color | ColorM | Power | Modes* | Imaging | Pulse | Other | ||
| Ophthalmic | |||||||||||
| Fetal/OB | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify)[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | P | P | P | P | P | P | P | P | P | ||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | ||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K121063)
[1] Abdominal includes GYN and Urological Notes:
[2] Small Organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
[1] Combined modes are B/M, B/Color M, B/PWD. B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 10 of 10
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number_
§ 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.