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K Number
K112213
Device Name
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
GE HEALTHCARE
Date Cleared
2011-09-01

(30 days)

Product Code
IYN,ITX,IYO
Regulation Number
892.1550
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
K101236,K101149
Predicate For
K113758,K120741,K122114
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

Device Description

The Voluson E6/E8/E8Expert/E10 system is a full-featured ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.

AI/ML Overview

This is a summary of the clinical evidence for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System.

The provided document is a 510(k) Premarket Notification Submission for the GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System. It states that clinical studies were not required to support substantial equivalence for this device. Therefore, it does not contain specific acceptance criteria, study data, or performance metrics in the way a clinical trial report would.

Instead, the document asserts substantial equivalence to a predicate device (K101236 Voluson E6/E8/E8Expert Diagnostic Ultrasound System and K101149 Vivid E9 Diagnostic Ultrasound System) based on:

  • The device employing the same fundamental scientific technology.
  • Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety, conforming with applicable medical device safety standards.
  • Compliance with voluntary standards detailed in sections 9, 11, and 17 of the premarket submission (not provided in this excerpt).
  • Quality assurance measures applied to development, including risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, final acceptance testing (validation), performance testing (verification), and safety testing (verification).

The "acceptance criteria" for this type of submission are implicitly that the device demonstrates it is as safe and as effective as the predicate device(s) and performs its intended functions according to established standards. The tables provided list the various transducers and their cleared "modes of operation" for different clinical applications. The "P" in these tables denotes "previously cleared by FDA," indicating that these functionalities are already accepted based on the predicate device. "N" indicates new indications, and "E" indicates additions under Appendix E.

Given that no clinical study was conducted for this 510(k) submission, the following information cannot be extracted from the provided text:

  1. Table of Acceptance Criteria and Reported Device Performance: No specific performance metrics or acceptance criteria from a clinical study are provided, as no clinical study was performed. The "performance" is considered substantially equivalent to the predicate.

  2. Sample Size for Test Set and Data Provenance: Not applicable, as no clinical test set was used.

  3. Number of Experts and Qualifications for Ground Truth: Not applicable, as no ground truth from human experts for a test set was established in a clinical study context.

  4. Adjudication Method: Not applicable.

  5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done, as stated that clinical studies were not required.

  6. Standalone (Algorithm Only) Performance Study: Not applicable, as this is an ultrasound system, not an AI algorithm.

  7. Type of Ground Truth Used: Not applicable. The basis for clearance relies on substantial equivalence to existing devices and verification of technical and safety standards.

  8. Sample Size for Training Set: Not applicable, as this device does not appear to be an AI/ML algorithm that would require a training set.

  9. How Ground Truth for Training Set was Established: Not applicable.

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Image /page/0/Picture/9 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. There are decorative swirls around the letters within the circle. The logo is black and white.

SEP - 1 2011

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided.

August 1, 2011 Date: Submitter: GE Healthcare [GE Healthcare Austria GmbH & Co OG] Tiefenbach 15 Zipf, Austria 4871 Bryan Behn Primary Contact Person: Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 Roland Kuntscher Secondary Contact Person: Regulatory Affairs Specialist GE Healthcare Austria GmbH & Co OG T:(++43)7682-3800-660 F:(++43)7682 3800-47 Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Device: Trade Name: Common/Usual Name: Voluson E6/E8/E8Expert/E10 Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K101236 Voluson E6/E8/E8Expert Diagnostic Ultrasound System K 101149 Vivid E9 Diagnostic Ultrasound System The Voluson E6/E8/E8Expert/E10 system is a full-featured Track Device Description: 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes. The device is a general purpose ultrasound system. Specific Intended Use:

clinical applications remain the same as previously cleared:

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Image /page/1/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 appear to be handwritten or cursive. The logo is black and white, with the letters and frame being black and the background being white.

Substantial Equivalence:

GE Healthcare

510(k) Premarket Notification Submission

Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular: Vascular: Transvaginal: Transrectal: and Peripheral Intraoperative (abdominal, PV and neurological).

The Voluson E6/E8/E8Expert/E10 employs the same Technology: fundamental scientific technology as its predicate devices.

Summary of Non-Clinical Tests: Determination of

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 with applicable medical device safety standards. The Voluson E6/E8/E8Expert/E10 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were 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.

Summarv of Clinical Tests:

The subject of this premarket submission, Voluson E6/E8/E8/ Expert/E10, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Voluson E6/E8/E8 Expert/E10 to be Conclusion: as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or abstract human figure with outstretched arms, symbolizing care and protection.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Drive WAUWATOSA WI 53226

1 2011

Re: K112213

Trade/Device Name: Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550

Regulation Name: Ultrasonic pulsed doppler imaging system

  • Regulatory Class: II
    Product Code: IYN. IYO. and ITX

  • Dated: August 1, 2011

  • Received: August 2, 2011

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 E6/E8/E8Expert/E10 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
RAB2-5-DPA6-8-D3S-DRRE5-10-D
RAB4-8-DSP10-16-DP2DRM14L
RIC5-9-DRSP6-16-DP6D3Sp-D
RNA5-9-DRIC6-12-DM6CC4-8-D
RRE6-10-DRAM3-811L-DRAB6-D
AB2-7-DRSM5-14C1-5-DeM6C
4C-D9L-DML6-15-D
IC5-9-DM12LWRM6C

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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 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.html 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 Robert Ochs, Ph.D. at (301) 796-6661.

Sincerely Yours.

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are solid black, creating a strong contrast against the white background. The logo is a well-known symbol representing the multinational conglomerate.

K112213 510(k) Number (if known):

Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System Device Name:

Indications for Use:

The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB: Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculoskeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Mary S Patel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K112213

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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 letters and the border are black, creating a strong contrast.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson E6/E8/E8Expert/E10 system and for all of its probe/mode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified Voluson E6/E8/E8Expert. In a similar manner, "E" represents combinations added to the unmodified Voluson E6/E8/E8Expert via Guidance Appendix E. This modification did not alter the previously cleared system level indications or clinical applications.

Mary S. Pastel

510K K112213

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "g" and "e" intertwined within a circle. The letters are stylized and connected, and there are decorative swirls around the outer edge of the circle.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationBMPWCWColor#Color MPowerCombined*HarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[ 5,6,9]
Abdominal[1]PPPPPPPPPP[ 5,6,9]
PediatricPPPPPPPPPP[ 5,6,9]
Small Organ[2]PPPPPPPPPP[ 5,6,9]
Neonatal CephalicPPPPPPPPPP[ 5 ]
Adult CephalicPPPPPPPPPP
Cardiac[3]PPPPPPPPPP[ 5 ]
Peripheral VascularPPPPPPPPPP[ 5,6,9]
Musculo-skeletal ConventionalPPPPPPPPPP[ 5,6,9]
Musculo-skeletal SuperficialPPPPPPPPPP[ 5,6,9]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]PPPPPPPPPP[ 5,6,9]
TransvaginalPPPPPPPPPP[ 5,6,9]
Transuretheral
IntraoperativePPPPPPPPPP
Intraoperative NeurologicalPPPPPPPPPP
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

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.

Prescription User (Per 21 CFR 801.109)

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] 4D color Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIV

Mary S. Pettit

vision Sion-Off of Radiological Device tic Device Evaluation and Safety nifice of in Vitro Diag

510K K112213

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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 circle. There are three decorative swirls around the letters inside the circle.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RAB2-5-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of InterestMode of Operation
BMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Padell

insion Sion-Of of Radiological Dev ation and Safety

K112213
510K
16

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The letters and the frame are black, creating a strong contrast against the white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RAB4-8-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Slatel

Office of I on and Safety

K112213
510K.

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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 letters and the border are solid black, contrasting with the white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RIC5-9-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModes*ImagingPulse[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6,9]
Abdominal[1]
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]PPPPPPPPP[5,6,9]
TransvaginalPPPPPPPPP[5,6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[5] 3D/4D Imaging Mode Notes:

[6] Includes imaging of guidance of biopsy (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 or CWD, B/Color/PWD or CWD, B/Power/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)

Mary S. Patel
(Division Sign-Off)

Office of In

510K K112213

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Image /page/10/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 and the frame are solid black, contrasting with the white background. The logo is a well-known symbol associated with the multinational conglomerate company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RNA5-9-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPPP[5,6]
PediatricPPPPPPPPPP[5,6]
Small Organ[2]PPPPPPPPPP[5,6]
Neonatal CephalicPPPPPPPPPP[5]
Adult Cephalic
Cardiac[3]PPPPPPPPPP[5]
Peripheral VascularPPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPPP[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; E = added under Appendix E

[1] Abdominal is Neonatal and pediatric Notes:

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Neonatal and Pediatric.

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mary S Pastl
(Division Sign-Off)
Division of Radiological Devices

Office of In aluation and Safety

510K K112213

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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a stylized circular shape. The letters and the surrounding shape are in black, contrasting with a white background. The logo is a well-known symbol associated with the General Electric company.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RRE6-10-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
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]PPPPPPPPP[5,6]
TransvaginalPPPPPPPPP[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[5] 3D/4D Imaging Mode Notes:

[6] Includes imaging of guidance of biopsy (3D/4D)

[8] Includes urology/prostate

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patil

Onvision Sign-C Division of Radiological De Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112213

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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, creating a strong contrast. The logo has a vintage or classic appearance.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with AB2-7-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[6]
Abdominal[1]PPPPPPPPP[6]
PediatricPPPPPPPPP[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

of Radiological De nivisio Office of In Vitro Di

K112213
510K

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, intertwined script, enclosed within a circular border. The background is black, and the letters and border are white, creating a high-contrast design. The logo is a well-known corporate symbol.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with 4C-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[6]
Abdominal[1]PPPPPPPPPP[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPPP[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Patil
(Division Sign Off)

Division q Radininnin Office of In Vitro Diag

S10K K112213

{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 logo is black and white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with IC5-9-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[6,9]
Abdominal[1]
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]PPPPPPPPP[6,9]
TransvaginalPPPPPPPPP[6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [6] Includes imaging of guidance of biopsy (2D)

[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 or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastil
(Division Sign-Off)

Office of In aluation and Safety

510K K112213

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular frame. The letters are stylized and connected, creating a unique and recognizable design. The logo is presented in black and white, with the letters and the inner part of the circle filled in black, while the background is white. The circular frame surrounding the letters has decorative elements, adding to the overall aesthetic appeal of the logo.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with PA6-8-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationBMPWCWColorColor MPowerCombinedHarmonicCodedOther
Anatomy/Region of InterestDopplerDopplerDopplerDopplerDopplerModesImagingPulse[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal CephalicPPPPPPPPPP
Adult Cephalic
Cardiac[3]PPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal is Neonatal , pediatric and obstetrics

[3] Cardiac is Adult and Pediatric.

Notes:

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patil
(Division Sign-Off)

Division of Ra Office of In luation and Safety

510K K112213

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the circle are black, creating a strong contrast.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with SP10-16-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[6]
Small Organ[2]PPPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[6]
Musculo-skeletal Conventional
Musculo-skeletal SuperficialPPPPPPPPP[6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes: [6] Includes imaging of guidance of biopsy (2D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patil

(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112213

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters and the circle are black, creating a strong contrast against the white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with RSP6-16-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[5,6]
Small Organ[2]PPPPPPPPP[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal SuperficialPPPPPPPPP[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
IntraoperativePPPPPPPPP
Intraoperative NeurologicalPPPPPPPPP
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Postell

(Division Sign Off)

Office of In Vitro Diagn

510K K112213

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters and the circle are black, and the background is white. There are decorative swirls around the inside of the circle.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RIC6-12-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]
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]PPPPPPPPP[5,6]
TransvaginalPPPPPPPPP[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patil
(Division Sign-Off)

Division of Radiological Devices Office of In Diagnostic Device Evaluation and Safety'

510K. K112213

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. There are three small swirls or flourishes equally spaced around the outside of the circle.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RAM3-8 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOtherNotes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mary S Patil
(Division Sign Off)

Division (Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K

28

{20}------------------------------------------------

Image /page/20/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 in black, set against a white background. The logo is a well-known corporate symbol.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RSM5-14 Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics(7)
Abdominal(1)
PediatricPPPPPPPPP[5,6]
Small Organ(2)PPPPPPPPP[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac(3)
Peripheral VascularPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal SuperficialPPPPPPPPP[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mary S Patil
(Division Sign-Off)

Division of Radiological Devices ice Evaluation and Safety Office of In

K112213
510K

{21}------------------------------------------------

Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. There are decorative swirls or flourishes around the circle, adding a stylized element to the design. The logo is presented in black and white.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with 9L-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPPP[6]
Small Organ[2]PPPPPPPPPP[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPPP[6]
Musculo-skeletal ConventionalPPPPPPPPPP[6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[6] Includes imaging of guidance of biopsy (2D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel

Division of Radiological Devices Office of In Vitr uation and Safety

510K K 112213

{22}------------------------------------------------

Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and appear to be in a cursive font. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with M12LW Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes^Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[6]
Small Organ[2]PPPPPPPPP[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[6]
Musculo-skeletal ConventionalPPPPPPPPP[6]
Musculo-skeletal SuperficialPPPPPPPPP[6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes: [6] Includes imaging of guidance of biopsy (2D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel

(Division Sign Off)

Office of In stic Device Evaluation and Safety

510K. K112213

{23}------------------------------------------------

Image /page/23/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the perimeter, giving it a vintage or classic appearance. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with 3S-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
ClinicalApplicationAnatomy/Regionof InterestBMPWDopplerCWDopplerColorDopplerColorMDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther(Notes)
Ophthalmic
Fetal /PPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal
Adult CephalicPPPPPPPPPPP
Cardiac [3]PPPPPPPPPPP
Peripheral
Musculo-skeletal
Musculo-skeletal
Other
Exam Type,
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic

[3] Cardiac is adult and Pediatric

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mary S. Patel

(Division Sign-Off)

on of Radiological Devices vice Evaluation and Safety Office of In

510K. K 112213

{24}------------------------------------------------

Image /page/24/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 black, creating a strong contrast against the white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with P2D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult CephalicP
Cardiac[3]P
Peripheral VascularP
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[3] Cardiac is adult and Pediatric Notes:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel
(Division Sign-Off)

Office of In iagnostic Device Evaluation and Safety

510K K112213

{25}------------------------------------------------

Image /page/25/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, giving them a flowing appearance. The logo is presented in black against a white background, creating a high contrast that makes it easily recognizable.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with P6D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]P
Peripheral VascularP
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [3] Cardiac is adult and Pediatric

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel

Division of Radiot valuation and Safety Office of In

510K K112213

{26}------------------------------------------------

Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are in black, contrasting with the white background. The logo has a vintage or classic appearance.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with M6C Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther(Notes)
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[6]
Abdominal[1]PPPPPPPPPP[6]
PediatricPPPPPPPPPP[6]
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
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mary Pastel

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112213

{27}------------------------------------------------

Image /page/27/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are black, creating a strong contrast. The logo is simple and recognizable, representing the well-known multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with 11L-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[6,9]
Small Organ[2]PPPPPPPPP[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral VascularPPPPPPPPP[6,9]
Musculo-skeletal ConventionalPPPPPPPPP[6,9]
Musculo-skeletal SuperficialPPPPPPPPP[6,9]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[6] Includes imaging of guidance of biopsy (2D)

[9] Elastography Imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112213

{28}------------------------------------------------

Image /page/28/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular frame. The letters are stylized with curved lines, and the frame has decorative flourishes. The logo is presented in black and white, with the letters and frame appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson E6/E8/E8Expert/E10 with C1-5-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP[6]
Abdominal[1]PPPPPPPPPP[6]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral VascularPPPPPPPPPP[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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 801.10)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

શાભા

37

{29}------------------------------------------------

Image /page/29/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 and the frame are in black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with ML6-15-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[6,9]
Small Organ[2]PPPPPPPPP[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[6,9]
Musculo-skeletal ConventionalPPPPPPPPP[6,9]
Musculo-skeletal SuperficialPPPPPPPPP[6,9]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication: P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[6] Includes imaging of guidance of biopsy (2D)

[9] Elastography Imaging-Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Pastel
(Bidder - Sign Off)

Office of in Vitro

510K K112213

{30}------------------------------------------------

Image /page/30/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, creating a strong contrast. The logo is simple, recognizable, and represents the brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RM6C Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined ModesHarmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[5,6]
Abdominal[1]PPPPPPPPP[5,6]
PediatricPPPPPPPPP[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic, Urology Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mani S. Patel
(Division Sign-Off)

Division of Radiological Devices ostic Device Evaluation and Safety

510K112213

{31}------------------------------------------------

Image /page/31/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The circle is black, and the letters are white. There are decorative swirls around the outside of the circle.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RRE5-10-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
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]PPPPPPPPP[5,6,9]
TransvaginalPPPPPPPPP[5,6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[8] Includes urology/prostate

[9] Elastography Imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)
stel

ion of Radictogical Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112213.

{32}------------------------------------------------

Image /page/32/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. There are three decorative swirls equally spaced around the inside of the circle.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RM14L Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
PediatricPPPPPPPPP[5,6]
Small Organ[2]PPPPPPPPP[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[5,6]
Musculo-skeletal ConventionalPPPPPPPPP[5,6]
Musculo-skeletal SuperficialPPPPPPPPP[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients Notes:

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mary S. Pastel
(Division Sign-Off)

of Radiological Do Office of In Birlsforn of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112213

{33}------------------------------------------------

Image /page/33/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with 3Sp-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPPP
Abdominal[1]PPPPPPPPPP
PediatricPPPPPPPPPP
Small Organ[2]
Neonatal Cephalic
Adult CephalicPPPPPPPPPP
Cardiac[3]PPPPPPPPPP
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

[1] Abdominal includes renal, GYN/Pelvic Notes:

[3] Cardiac is adult and Pediatric

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mays. Patel
(Division Sign-Off)
Division of Radiological Devices

Divisi Office of In Vitro D

K112213
$10K

{34}------------------------------------------------

Image /page/34/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular shape. The letters and the circle are filled with a solid black color, creating a strong contrast against the white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with C4-8-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColorDopplerColor MDopplerPowerDopplerCombinedModes*HarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]PPPPPPPPP[6]
Abdominal[1]PPPPPPPPP[6]
PediatricPPPPPPPPP[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral VascularPPPPPPPPP[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

[6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patel

(Division Sign-Off)

Division of Radiological Device Office of In Vitro Diagnostic Dev

510K R112213

{35}------------------------------------------------

Image /page/35/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'g' and 'e' intertwined within a circular border. The letters are stylized in a cursive font, and the border has small, rounded embellishments. The logo is presented in black and white, with the letters and border appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with RAB6-D Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPW DopplerCW DopplerColor DopplerColor M DopplerPower DopplerCombined Modes*Harmonic ImagingCoded PulseOther [Notes]
Ophthalmic
Fetal / Obstetrics[7]EEEEEEEEEE[5,6]
Abdominal[1]EEEEEEEEEE[5,6]
PediatricEEEEEEEEEE[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalEEEEEEEEEE[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/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)

Mary S Patel

(Division Sign-Off)

Barlinknowiczl Not Atice of In

510K K112213

{36}------------------------------------------------

Image /page/36/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, giving the logo a classic and recognizable look.

Diagnostic Ultrasound Indications for Use Form

GE Voluson E6/E8/E8Expert/E10 with eM6C Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical ApplicationAnatomy/Region of InterestBMPWDopplerCWDopplerColor#DopplerColor MDopplerPowerDopplerCombinedModesHarmonicImagingCodedPulseOther[Notes]
Ophthalmic
Fetal / Obstetrics[7]NNNNNNNNN[5,6]
Abdominal[1]NNNNNNNNN[5,6]
PediatricNNNNNNNNN[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal ConventionalNNNNNNNNN[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes renal, GYN/Pelvic, Urology

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (3D/4D)

[7] Includes infertility monitoring of follicle development

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

[*] 4D color Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Postel

Office of In

510K 112213

§ 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.