(30 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric: Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The medical device in question, the GE Voluson P6, Voluson P8 Ultrasound System, is a general-purpose ultrasound system. The provided information does not detail a study that defines specific acceptance criteria for a new AI feature or algorithm. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K132913 Voluson E Series and K122387 Voluson P6/P8).
The "acceptance criteria" presented here are inferred from the declaration of substantial equivalence, which implies that the device must perform equivalently to its predicates across various clinical applications and imaging modes. The "reported device performance" is the statement that the device IS substantially equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| General System Performance: | |
| - Safety: Conformance to applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set). | - The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. Voluson P6/P8 and its applications comply with listed voluntary standards. |
| - Effectiveness: Equivalent imaging capabilities, technological characteristics, and safety as predicate devices. | - The Voluson P6/P8 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. |
| - Intended Use: Support diagnostic ultrasound imaging and fluid flow analysis for specified clinical applications (Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Transrectal, Transvaginal). | - The Voluson P6/P8 and predicate Voluson P6/P8 systems have the same clinical intended use. - The device supports the intended uses and modes of operation as detailed in the Indications for Use forms (Pages 7-14), with 'P' indicating applications previously cleared by FDA for the predicate devices. |
| - Acoustic Power Levels: Below applicable FDA limits. | - The systems have acoustic power levels which are below the applicable FDA limits. |
| - Transducers: Identical to predicate Voluson P6/P8 systems. | - The Voluson P6/P8 and predicate Voluson P6/P8 systems transducers are identical. The submission lists the following transducers: RAB2-6-RS, 4C-RS, E8C-RS, 12L-RS, RICS-9W-RS, RAB2-5-RS, 3S-RS. |
| - Digital Imaging & Reporting: Similar capability in performing measurements, capturing digital images, reviewing and reporting studies as predicate devices. | - The Voluson P6/P8 and predicate Voluson P6/P8 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. |
| - New Software Features (HDLive, Sono IT, SonoBiometry, Sono L&D): Same features cleared on predicate Voluson E Series (K132913). | - New software features added to Voluson P6/P8: HDLive, Sono IT, SonoBiometry and Sono L&D are the same features cleared on predicate Voluson E Series (K132913). |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document indicates that no clinical studies were required to support the substantial equivalence claim for the Voluson P6, Voluson P8. Therefore, there is no specific test set sample size and no data provenance (country of origin, retrospective/prospective) related to clinical performance testing for this submission. The evaluation was based on non-clinical tests and comparison to predicate device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical studies were performed, there was no ground truth established by experts for a test set in the context of this 510(k) submission.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
As no clinical studies were performed, there was no adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was performed as indicated by the statement: "The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The submission does not describe a standalone algorithm performance study. The "new software features" (HDLive, Sono IT, SonoBiometry, Sono L&D) are stated as being "the same features cleared on predicate Voluson E Series (K132913)," implying their performance was already established, likely as part of the predicate device's clearance.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" used for demonstrating substantial equivalence was effectively the established safety and performance of the predicate devices. The device's compliance was evaluated against established medical device safety standards and the known characteristics of the predicate systems. There was no de novo clinical ground truth establishment in this submission.
8. The Sample Size for the Training Set
Since no new AI algorithms requiring a training set are explicitly detailed as being newly developed and tested for this submission (rather, the new features are already cleared on a predicate), no training set sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
As no new training set is described, no information on how ground truth was established for a training set is provided. The substantial equivalence argument relies on the prior clearance of features on predicate devices.
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JUL 25 2014
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The letters are stylized with curved lines and a flowing design, and the circle has three decorative swirls around it.
K141675
Page 1 of 4
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: June 24, 2014
GE Healthcare . Submitter: 9900 Innovation Dr Wauwatosa, WI 53226
Primary Contact Person:
Secondary Contact Person:
Bryan Behn Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 Chansook KIM Regulatory Affairs Leader GE Healthcare T:(+82) 31 740-6307
Voluson P6, Voluson P8 Ultrasound System Device: Trade Name: Common/Usual Name: Voluson P6. Voluson P8 Classification Names:
Product Code:
Class II
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):
K132913 Voluson E Series
K 122387 Voluson P6/P8
The subject device consists of a mobile console with keyboard, Device Description: specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric: Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV);
Intended Use:
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GE Healthcare
510(k) Premarket Notification Submission
Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
The Voluson P6. Voluson P8 employs the same fundamental Technology: scientific technology as its predicate devices
Determination of Substantial Equivalence:
Comparison to Predicate Device(s):
The Voluson P6/P8 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound . imaging and fluid flow analysis.
- . The Voluson P6/P8 and predicate Voluson P6/P8 systems have the same clinical intended use
- The Voluson P6/P8 and predicate Voluson P6/P8 systems . have the same imaging modes.
- . The Voluson P6/P8 and predicate Voluson P6/P8 systems transducers are identical.
- The systems are manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
- . The systems have acoustic power levels which are below the applicable FDA limits.
- The Voluson P6/P8 and predicate Voluson P6/P8 systems . have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- New software features added to Voluson P6/P8: HDLive, . Sono IT, SonoBiometry and Sono L&D are the same features cleared on predicate Voluson E Series(K132913).
- . The Voluson P6/P8 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output. biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. Voluson P6/P8 and its applications comply with
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voluntary standards;
- l. 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)
- Final Acceptance Testing (Validation) .
- Performance testing (Verification) �
- . Safety testing (Verification)
Transducer materials and other patient contact materials are biocompatible.
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GE Healthcare
510(k) Premarket Notification Submission
Summary of Clinical Tests:
The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the Voluson P6, Voluson P8 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K141675
Trade/Device Name: Voluson P6, Voluson P8 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: June 24, 2014 Received: June 25, 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 Voluson S6, Voluson S8 Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | ||
|---|---|---|
| RAB2-6-RS | 4C-RS | E8C-RS |
| 12L-RS | RICS-9W-RS | RAB2-5-RS |
| 38c-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.
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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.goy/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) K141675
Device Name
Voluson P6/Voluson P8 Diagnostic Ultrasound System
Indications for Use (Describe)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, thyroid, salivary gland, lymph nodes, pediatric and neonatal Cephalic; Adult Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).
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: 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)
Smh)
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."
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Diagnostic Ultrasound Indications for Use Form GE Voluson P6/P8 Ultrasound System
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Anatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other[Notes] |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5] | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | ||
| Cardiac[1] | P | P | P | P | P | P | P | P | P | P | [5] | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Other | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[4] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA
No1cs: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, thyroid, salivary gland, lymph nodes, pediatric and neonatal patiens
[3] Cardiac is Adult and Pediatric.
15| 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate
[9] Elastography imaging. Elasticity
[*] 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 User (Per 21 CFR 801.109)
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Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with RAB2-6-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other(Notes) |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics71 | P | P | P | P | P | P | P | P | P | (5,6) | |
| Abdominal1 | P | P | P | P | P | P | P | P | P | (5.6) | |
| Pediatric | |||||||||||
| Small Organ2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac3) | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | (5,6) | |
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal4) | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication: P = previously cleared by FDA
[1] Abdominal includes renal, GYN/Pelvic Noics:
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediative and neonatal patients
|3| Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/JD/4D)
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE DELOW TIJIS LINE - CONTINUE ON ANOTIER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 3 of 9
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Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with 4C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other(Notes) |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[1] | P | P | P | P | P | P | P | P | P | [6] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | [6] | |
| Pediatric | P | P | P | P | P | P | P | P | P | [6] | |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[1] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | [6] | |
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[3] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N - new indication: P = previously cleared by FDA
| | | Abdominal includes renal, G YN/Pelvic Noics:
|2] Small organ includes breast, testes. thyroid, salivary gland, lymph nodes, pediatric and neonatal patients [3] Cardiac is Adult and Pediatric.
15] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (2D/JD/4D).
[7] Includes infertifity monitoring of follicle development.
[8] Includes urology/prosialc.
- Elastography imaging- Elasticity
[*] 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 User (Per 21 CFR 801.109)
Page 4 of 9
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Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with E8C-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | [6] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | [6] | |
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | [6] | |
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[4] | P | P | P | P | P | P | P | P | P | [6] | |
| Transvaginal | P | P | P | P | P | P | P | P | P | [6] | |
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication: P = previously cleared by FDA
[I] Abdominal includes renal, GYN/Pelvic Noles:
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
(8) Includes urology/prostate
[9] Elastography imaging- Elasticity
[ ] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW TIJIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 5 of 9
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and connected, and the frame has decorative swirls or flourishes around it. The logo is in black and white.
Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with 12L-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other[Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics17 | |||||||||||
| AbdominalII | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | [6,9] | |
| Small OrganII | P | P | P | P | P | P | P | P | P | [6,9] | |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| CardiacI | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | [6,9] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | [6,9] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | [6.9] | |
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| TransrectalII | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication: P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, tymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
{7} Includes infertility monitoring of follicle development.
18] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
(PLEASE DO NOT WRITE BELOW THIS 1.INE - CONTINIJE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 6 of 9
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The letters are stylized and connected, and the circle has a textured or shaded appearance.
Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with RICS-9W-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes' | HarmonicImaging | CodedPulse | Other[Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[1] | P | P | P | P | P | P | P | P | P | [5,6] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | [5,6] | |
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[1] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[4] | P | P | P | P | P | P | P | P | P | [5,6] | |
| Transvaginal | P | P | P | P | P | P | P | P | P | [5,6] | |
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes rena!, GYN/Pelvic
(2) Small organ includes breast, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prosiate
19| Elastography imaging- Elasticity
[ ° ] 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 User (Per 21 CFR 801.109)
Page 7 of 9
{13}------------------------------------------------
Image /page/13/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 logo is black and white and has a vintage look.
Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with RAB2-S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes] |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal / Obstetrics1 | P | P | P | P | P | P | P | P | P | (5,6) | |
| Abdominal1 | P | P | P | P | P | P | P | P | P | (5,6) | |
| Pediatric | |||||||||||
| Small Organ1 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac1 | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | (5,6) | |
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal1 | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N - new indication; P - previously cleared by FDA
[1] Abdominat includes renal. GYN/Pelvic Nolcs:
[2] Small organ includes breast, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] includes imaging of guidance of biopsy (2D/3D/4D).
[ 7] Includes infertility monitoring of follicle development.
{8} Includes urology/prosiate.
[9] Elastography imaging- Elasticity
[ °] 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 Heallh (OIR)
Prescription User (Per 21 CFR 801.109)
Page 8 of 9
{14}------------------------------------------------
Image /page/14/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 hand-drawn or calligraphic. The logo is black and white.
Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with 3Sc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other[Notes] |
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics1 | P | P | P | P | P | P | P | P | P | P | [6] |
| Abdominal11 | P | P | P | P | P | P | P | P | P | P | [6] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [6] |
| Small Organ2 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [6] |
| Cardiac11 | P | P | P | P | P | P | P | P | P | P | [6] |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal11 | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication: P = previously cleared by FDA
No1cs: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
| 3) Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate
[9] Elastography imaging- Elasticity
(*) 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 User (Per 21 CFR 801.109)
Page 9 of 9
§ 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.