(36 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).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application / Anatomy/Region of Interest: Ophthalmic; Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other.
Exam Type, Means of Access: Transesophageal; Transrectal; Transvaginal; Transuretheral; Intraoperative; Intraoperative Neurological; Intravascular; Laparoscopic.
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronic-array transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 general-purpose 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 provided 510(k) summary for the GE Healthcare Voluson P6, Voluson P8 Ultrasound System states explicitly:
"The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence."
Therefore, no acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study results are detailed in this document. The submission relies on non-clinical tests and substantial equivalence to predicate devices (K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System and K113758 Voluson E6E8E8ExpertE10) to demonstrate safety and effectiveness.
The document lists conformity to applicable medical device safety standards for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. It also mentions quality assurance measures during development, such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, and safety).
Therefore, I cannot provide the requested information regarding acceptance criteria and clinical study results as this device did not require clinical studies for its 510(k) submission.
{0}------------------------------------------------
K12238.7
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 03, 2012 |
|---|---|
| Submitter: | GE Healthcare9900 Innovation DrWauwatosa, WI 53226 |
| Primary Contact Person: | Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275 |
| Secondary Contact Person: | Sadashiva SubrayaRegulatory Affairs LeaderGE HealthcareT:(+91)80-40882969 |
| Device: | Voluson P6, Voluson P8 Ultrasound System |
| Trade Name: | Voluson P6, Voluson P8 Ultrasound System |
| Common/Usual Name: | Voluson P6, Voluson P8 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-ΙΥΝUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound SystemK113758 Voluson E6E8E8ExpertE10 |
| Device Description: | The subject device consists of a mobile console with keyboard,specialized controls, a color video LCD display with electronic-array transducers. It has the same general appearance, dimensionsand weight as the unmodified device, it is a Track 3 general-purpose imaging and analysis system providing real-time digitalacquisition, processing and display capability intended forgeneral radiology imaging and evaluation with some cardiologyand vascular applications. |
| Intended Use: | The device is a general-purpose ultrasound system.Specificclinical applications and exam types include: Fetal (Obstetrics);Abdominal (including renal and GYN/pelvic); Pediatric; SmallOrgan (breast, testes, thyroid, salivary gland, lymph nodes,pediatric and neonatal patients); Neonatal Cephalic; AdultCephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); |
Image /page/0/Picture/7 description: The image shows a circular logo with the letters 'GE' intertwined in the center. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is surrounded by a circular border with a decorative, swirling pattern. The image is in black and white, and the logo appears to be a vintage or classic design.
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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 in a circular design. The logo is black and white and has a vintage look.
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:
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, Voluson P8 and its applications comply with voluntary standards:
- I. IEC60601-1, 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 5. 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 were applied to the development of the system:
- Risk Analysis .
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white and has a vintage look.
GE Healthcare
510(k) Premarket Notification Submission
- . 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.
Summary of Clinical Tests:
�
The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Voluson P6, Voluson P8 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 11
2012
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226
Re: K122387
Trade/Device Name: Voluson P6, Voluson P8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 3, 2012 Received: August 6, 2012
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Voluson P6, Voluson P8, as described in your premarket notification:
Transducer Model Number
| RAB2-6-RS | RIC5-9W-RS |
|---|---|
| 4C-RS | RAB2-5-RS |
| E8C-RS | 3Sc-RS |
| 12L-RS |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can
{4}------------------------------------------------
be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours,
hm D'A
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
Image /page/5/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 in black and white, with the letters and border appearing in black against a white background.
510(k) Number (if known):
Voluson P6, Voluson P8 Device Name:
Indications for Use:
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 (Including Urology and Prostate) (TR); Transvaginal (TV).
Prescription Use_X_ (Part 21 CFR 801 Subpart D)
Over-Th
(Part 3)
Over-The-Counter Use_NA (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
AND/OR
Mahal D. Okh
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number
{6}------------------------------------------------
Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson P6, Voluson P8 system. Combinations identified "P" for the transducers represents those previously cleared with this or another GE Ultrasound system. Combinations identified "N" for the transducers represents those not previously cleared any GE Ultrasound system. Please see section 11 Table 11.2.1 for information on previous clearance information on these transducers.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K112387
Confidential and Privileged. This document confidential and privileged trade secrets and other Countiential and I TIVITEESO. THIS decament volhants bethund and thers not employed by General Electric Co. All rights reserved
{7}------------------------------------------------
Image /page/7/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 connected, creating a recognizable monogram.
Diagnostic Ultrasound Indications for Use Form GE Voluson P6/P8 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined Harmonic | Coded | Other | |
| Anatomy/Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | [Notes] | ||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | N | N | N | ਨ | ਮ | N | N | N | ਮ | । | [ 5,6,9] |
| Abdomina[1] | Z | N | તિ | ત્વ | N | N | N | N | N | N | [ 5,6,9] |
| Pediatric | ਨ | N | N | N | N | N | N | N | N | N | [ 5,6,9] |
| Small Organ[2] | N | N | N | N | N | N | N | । A | N | N | [ 5,6,9] |
| Neonatal Cephalic | ત્વ | N | N | N | N | N | ત | N | ત્ત્વ | N | ારા |
| Adult Cephalic | N | N | N | N | N | ਨ | N | N | N | ਨ | |
| Cardiac الر | ನಿ | N | N | N | ਨ | N | N | ਨ | N | N | [ર] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | [5,6,9] | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | [5,6,9] | |
| Musculo-skeletal Superficial | પ | N | ત્વ | N | N | N | N | N | N | (5,6,9) | |
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal (8) | ાં | N | N | N | N | N | N | ਨ | N | 5,6,9) | |
| Transvaginal | N | N | N | ル | N | N | ਮ | N | N | (5,6,9) | |
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
Notes: [1] Abdominal includes renal, GYN/Pelvic
[1] Additinal mailudes form, OTTAT OFFS
[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
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Division of Radiological Devices
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows a logo of the General Electric (GE) company. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, giving the logo a classic and recognizable appearance.
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 / Obstetrics[7] | N | N | N | N | N | N | N | N | N | [5,6] | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | [5,6] | |
| Pediatric | N | N | N | N | N | N | N | N | N | [5,6] | |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | [5,6] | |
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes renal, GYN/Pelvic Notes:
[1] Abounliner molded Tonal, & Frestes, 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
[0] Liastography Imaging "Liaotics" Elaoston"
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
{9}------------------------------------------------
Image /page/9/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 in black and white.
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 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 | P | P | P | P | P | P | P | P | P | [6] | |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | |||||||||||
| 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[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K120741)
Notes: [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 Diagnostic Devices (OIVD)
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Prescription User (Per 21
(Division Sign-Off)
Division of Radiological Devices
{10}------------------------------------------------
Image /page/10/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 appears to be a vintage or classic version of the GE logo.
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] | |||||||||||
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | ||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type. Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | 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 (K120741)
Notes: [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
[0] Llactography "https://www.b/Color M, B/PWD, B/Color/PWD, B/PWD
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K22389
ETOK
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
{11}------------------------------------------------
Image /page/11/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 in black and white and appears to be a slightly distressed or vintage version.
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:
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes | HarmonicImaging | CodedPulse | Other[Notes] |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | [6,9] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | [6,9] | |
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| 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 | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K120741)
[1] Abdominal includes renal, GYN/Pelvic Notes:
[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
[5] Elastography Imaging "Elaosing" Elasting", "Elaosen", "B/Color/PWD , B/PWD
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Division of Radiological Devices
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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 border. The logo is in black and white.
Diagnostic Ultrasound Indications for Use Form GE Voluson P6/P8 with RIC5-9W-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined Harnonic | Coded | Other | |
| Anatomy/Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | [Notes) | ||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | b | P | P | P | [ 2,6] | |
| Abdominal(!) | |||||||||||
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac!3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type. Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal (8) | b | P | P | P | P | P | P | P | P | [ રું રો | |
| 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 (K120741)
Notes: [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 Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
Markel D. Dike
(Division Sign-Off)
Division of Radiological Devices
210k
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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 letters and the border are depicted in black, while the background is white.
Diagnostic Ultrasound Indications for Use Form
GE Voluson P6/P8 with RAB2-5-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 | (5,6) | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | (5,6) | |
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| 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 | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K120741)
[1] Abdominal includes renal, GYN/Pelvic Notes:
[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
[3] Clastography imaging "Elastion"
[*] 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 Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
510k ं :
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Image /page/14/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white, with the letters and border in black against a white background.
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 ApplicationAnatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other [Notes] | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | 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[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | ||
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | ||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K120741)
Notes: [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 Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices
210K
vices
§ 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.