VOLUSON P6, VOLUSON P8

• K Number: K122387
• Device Name: VOLUSON P6, VOLUSON P8
• Manufacturer: GE HEALTHCARE
• Date Cleared: 2012-09-11 ( 36 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended 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 (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.

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, 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.

Predicate Devices

K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System, K113758 Voluson E6E8E8ExpertE10

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms in the device description or other sections. The focus is on standard ultrasound imaging and processing capabilities.

Therapeutic

No
The device is described as a general-purpose ultrasound system used for diagnostic imaging and fluid flow analysis, not for therapeutic purposes.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "mobile console with keyboard, specialized controls, a color video LCD display with electronic-array transducers," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device used for imaging within the body, not for testing samples outside the body (which is the definition of in vitro).
• Device Description: The description details a "mobile console with keyboard, specialized controls, a color video LCD display with electronic-array transducers." This is consistent with an ultrasound imaging system, not an IVD device that would typically involve reagents, analyzers, or sample handling components.
• Anatomical Site: The listed anatomical sites are all parts of the human body being imaged directly. IVD devices analyze biological samples like blood, urine, or tissue.
• No mention of in vitro testing: There is no mention of analyzing samples, using reagents, or performing tests on biological materials outside of the body.

The device is a general-purpose ultrasound system used for diagnostic imaging of the human body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Product codes (comma separated list FDA assigned to the subject device)

90-ΙΥΝ, 90-IYO, 90-ITX

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, 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

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) (including urology/prostate); Transvaginal (TV).

Indicated Patient Age Range

Adult, Pediatric, Neonatal. Some applications specify pediatric and neonatal patients for Small Organ and Fetal.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System, K113758 Voluson E6E8E8ExpertE10

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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 Healthcare
9900 Innovation Dr
Wauwatosa, WI 53226
Primary Contact Person:	Bryan Behn
Regulatory Affairs Manager
GE Healthcare
T:[phone]
F:[phone]
Secondary Contact Person:	Sadashiva Subraya
Regulatory Affairs Leader
GE Healthcare
T:([phone]
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-ΙΥΝ
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):	K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System
K113758 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, 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.
Intended 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);

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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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
• 2. IEC60601-1-2,Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
• 3. IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
• 4. 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
• 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• 7. ISO14971, Application of risk management to medical devices
• 8. 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 .

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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).

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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

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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 [phone].

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)

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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)

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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

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

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices

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Diagnostic Ultrasound Indications for Use Form GE Voluson P6/P8 with RAB2-6-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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]	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)

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Diagnostic Ultrasound Indications for Use Form

GE Voluson P6/P8 with 4C-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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	[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)

Prescription User (Per 21 CFR 801.109)

Prescription User (Per 21

(Division Sign-Off)
Division of Radiological Devices

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Diagnostic Ultrasound Indications for Use Form GE Voluson P6/P8 with E8C-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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	[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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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

---

(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
K22389

ETOK

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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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 Application
Anatomy/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] | | | | | | | | | | | |
| 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

(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

ﻨﺔ ﻳﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

12

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular 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

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The 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 Application
Anatomy/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	(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 ं :

14

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 Application
Anatomy/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