The Versana Premier are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Muscular, Musculoskeletal Conventional, Musculos-keletal Superficial, Transcranial, Transvaginal, Tissue Biopsy/Fluid Drainage.

Device Description

The Versana Premier is a general purpose, diagnostic ultrasound system for use by qualified healthcare professionals. The system consists of a mobile console, operator control panel, display monitor and some transducers. The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. The operator control panel includes an ultrasound keyboard, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GE Versana Premier ultrasound system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness from scratch. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria for a novel device is not fully present.

However, based on the provided text, I can extract information related to the comparison with predicate devices, which serves as the basis for the FDA's substantial equivalence determination.

Here's an analysis of the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed reported device performance in a table for most features. Instead, it asserts "similar" or "same" characteristics when compared to predicate devices for many aspects. The main "performance" demonstrated is the similarity to the predicate devices.

Feature/Criterion	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Versana Premier)
Intended Use	Same as predicate devices	Same clinical indications for use as LOGIQ F8 (K160277)
Imaging Modes	Similar to predicate devices	Similar imaging modes to LOGIQ F8 (K160277)
Transducers	Similar to predicate devices	Similar to LOGIQ F8 (K160277) transducers. Specific new additions: - Coded Pulse mode (8C-RS, E8C-RS, RAB2-6-RS, E8Cs-RS) - Non-vascular access (4C-RS) - Vascular access and Non-vascular access (L6-12-RS) - RIC5-9A-RS transducer (newly added; applications from LOGIQ P9 K163596 for Transrectal, Tissue Biopsy/Fluid Drainage) - 12L-RS transducer (newly added; from LOGIQ P9 K163596, with added Coded Pulse mode and Non-vascular access) - LK760-RS transducer (newly added; from LOGIQ e K151028, with added Coded Pulse mode) - 12S-RS transducer (newly added; from LOGIQ P9 K163596, with added Power Doppler Imaging mode, Cardiac application from Vivid T8 K160078, and Transcranial application from Vivid iq K161706)
Features	Equivalent or improved compared to predicate devices	Added Vocal, Breast Productivity, Thyroid productivity, TVM (from LOGIQ P9 K163596) Added Needle recognition and Follow-Up tool (from LOGIQ e K151028) Added Auto Bladder Volume and Tricefy Uplink (from Vscan Extend K180995) Added new features: Breast Care 2.0 and Whizz
Hardware	Similar to predicate devices (with some additions)	Some new hardware added
Measurements, Digital Imaging, Reviewing, Reporting	Similar capability to predicate devices	Similar capability to LOGIQ F8 (K160277)
Materials	Safe for intended use	Manufactured with materials evaluated and found safe
Acoustic Output	Below applicable FDA limits	Below applicable FDA limits
Safety Standards	Designed in compliance with approved standards	Designed in compliance with approved electrical and physical safety standards; Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, NEMA PS 3.1-3.20 (DICOM)
Biocompatibility	Biocompatible	Transducer material and other patient contact materials are biocompatible

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence." This means no dedicated clinical test set (sample size, data provenance) was used for this submission to prove performance against specific acceptance criteria. The equivalence is based on the technical and functional similarity to already cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were performed for this submission, there was no "test set" requiring ground truth established by experts. The determination of substantial equivalence is an administrative and technical review process by the FDA, relying on a comparison to predicate devices, not on new clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Versana Premier is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation for improved human reader performance. Its purpose is imaging itself. No MRMC study was conducted or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Versana Premier is a physical ultrasound imaging system that requires a human operator, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new clinical studies were conducted for this premarket submission. The "ground truth" for the FDA's decision is the established safety and effectiveness of the identified predicate devices, based on previous clearances.

8. The sample size for the training set

Not applicable. This submission is for a medical imaging device, not a machine learning algorithm that requires a training set. The device's design and functionality are based on proven engineering principles and features from existing cleared devices.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA, WI 53226

November 21, 2018

Re: K182277

Trade/Device Name: Versana Premier Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: November 10, 2018 Received: November 13, 2018

Dear Tracey Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182277

Device Name Versana Premier

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Versana Premier. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

The following Indication for Use forms are appended:

System: Versana Premier Transducer: 4C-RS Transducer: 8C-RS Transducer: 3Sc-RS Transducer: L6-12-RS Transducer: E8C-RS Transducer: RAB2-6-RS Transducer: 6S-RS Transducer: L8-18i-RS Transducer: E8Cs-RS Transducer: BE9Cs-RS Transducer: 12L-RS Transducer: 12S-RS Transducer: LK760-RS Transducer: RIC5-9A-RS

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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' in a stylized script, enclosed within a blue circle. A thin blue line encircles the letters, creating a border within the circle.

GE Versana Premier Ultrasound System

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	B	M	Doppler Modes			CombinedModes*	HarmonicImaging	CodedPulse	Other
			PW	CW	Color	Color M	Power
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	N	N	N		N		N	N	N	N	[5][8]
Abdominal[1]	N	N	N		N		N	N	N	N	[5][6][8]
Pediatric	N	N	N	N	N		N	N	N	N	[8]
Small Organ [2]	N	N	N		N		N	N	N	N	[6][8]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	N	N	N	N	N		N	N	N	N	[8]
Peripheral Vascular	N	N	N		N		N	N	N	N	[8]
Musculo-skeletal Conventional	N	N	N		N		N	N	N	N	[8]
Musculo-skeletal Superficial	N	N	N		N		N	N	N	N	[8]
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	N	N	N	N	N		N	N	N	N
Transesophageal
Transrectal	N	N	N		N		N	N	N	N	[8]
Transvaginal	N	N	N		N		N	N	N	N	[8]
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	N	N	N		N		N	N	N	N	[8]
Vascular Access[7]	N		N		N		N	N	N	N	[8]
Non-vascular access	N							N	N	N	[8]

N = new indication;

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[*] Coded Pulse is for digitally encoded harmonics

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

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, and there are small, curved shapes around the letters, adding to the design.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with 4C-RS Transducer

Clinical Application	B	M	Doppler Modes				CombinedModes*	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest			PW	CW	Color	Color M	Power
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P	P	[8]
Abdominal[1]	P	P	P		P		P	P	P	P	[6][8]
Pediatric	P	P	P		P		P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P	P
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P				P		P	P	P	P	[8]
Vascular Access[7]
Non-vascular access	N							N	N	N	[8]

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

["] Coded Pulse is for digitally encoded harmonic

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/6/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 blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with 8C-RS Transducer

			Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P	P	P		P		P	P	P	N
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P		P		P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P		P	P	P	N
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid
Drainage[4]
Vascular Access[7]
Non-vascular access

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;

P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

[1] Abdominal includes GYN and Urological/Prostate; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

["] Coded Pulse is for digitally encoded harmonics

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with 3Sc-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P1	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	P	P	P	P3	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P	P			P		P	P	P		[8]
Vascular Access[7]
Non-vascular access

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;

P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[D] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with L6-12-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	B	Doppler Modes				CombinedModes*	Harmonic Imaging	CodedPulse	Other
		PW	CW	Color	Color M	Power
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P	P		P		P	P	P	P	[8]
Small Organ [2]	P	P		P		P	P	P	P	[6][8]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P		P		P	P	P	P	[8]
Musculo-skeletal Conventional	P	P		P		P	P	P	P	[8]
Musculo-skeletal Superficial	P	P		P		P	P	P	P	[8]
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance[4]
Tissue Biopsy/Fluid
Drainage[4]	P	P		P		P	P	P		[8]
Vascular Access [7]	N	N		N		N	N	N	N	[8]
Non-vascular access	N			N		N	N	N	N	[8]

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;

P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

[1] Abdominal includes GYN and Urological/Prostate; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

["] Coded Pulse is for digitally encoded harmonics

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with E8C-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	Doppler Modes				CombinedModes*	Harmonic Imaging	CodedPulse	Other
Anatomy/Region of Interest			PW	CW	Color	Color M	Power
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P	N	[8]
Abdominal[1]	P	P	P		P		P	P	P	N	[8]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal	P	P	P		P		P	P	P	N	[8]
Transvaginal	P	P	P		P		P	P	P	N	[8]
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P				P		P	P	P	N
Vascular Access [7]
Non-vascular access

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;

P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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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 in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with RAB2-6-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

		Mode of Operation
Clinical Application	B	M	Doppler Modes			CombinedModes*	HarmonicImaging	CodedPulse	Other
			PW	CW	Color	Color M				Power
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P	N	[5][8]
Abdominal[1]	P	P	P		P		P	P	P	N	[5][8]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P				P	P	P	P	P	N	[8]
Vascular Access[7]
Non-vascular access

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;

P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics

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{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with 6S-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse°	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P	P	P	P	P	P	P	P	P		[8]
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P		[8]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]
Vascular Access[7]
Non-vascular access

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics

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

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with L8-18i-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application			Mode of Operation
	B	M	PW	CW	Color	Color M	Power	Combined Modes*	Harmonic Imaging	Coded Pulse•	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ [2]	P	P	P		P		P	P	P		[8]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P		P	P	P		[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial	P	P	P		P		P	P	P		[8]
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage[4]
Vascular Access[7]
Non-vascular access

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics

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

{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 in a stylized, cursive font. The letters are white and are set against a blue circular background. The outer edge of the blue circle has a swirling, wave-like design.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with E8Cs-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical ApplicationAnatomy/Region of Interest	B	M	Doppler Modes					CombinedModes*	HarmonicImaging	CodedPulse	Other
			PW	CW	Color	Color M	Power
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P	N
Abdominal[1]	P	P	P		P		P	P	P	N	[6][8]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal	P	P	P		P		P	P	P	N	[8]
Transvaginal	P	P	P		P		P	P	P	N	[8]
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P	P	P		P		P	P	P	N
Vascular Access[7]
Non-vascular access

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by

FDA K160078

[1] Abdominal includes GYN and Urological/Prostate; Notes:

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with BE9CS-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M				Doppler Modes					Other
			PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal [1]	P	P	P		P		P	P	P		[8]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal	P	P	P		P		P	P	P		[8]
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid	P	P	P		P		P	P	P
Drainage[4]
Vascular Access[7]
Non-vascular access

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with 12L-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	P1		P1		P1		P1	P1	P1	P1	[8]
Small Organ [2]	P1		P1		P1		P1	P1	P1	P1	[6][8]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P1		P1		P1		P1	P1	P1	P1	[8]
Musculo-skeletal Conventional	P1		P1		P1		P1	P1	P1	P1	[8]
Musculo-skeletal Superficial	P1		P1		P1		P1	P1	P1	P1	[8]
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]	P2				P2		P2	P2	P2	P2	[8]
Vascular Access[7]	P2		P2		P2		P2	P2	P2	P2	[8]
Non-vascular access	N				N		N	N	N	N	[8]

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;

P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078

[1] Abdominal includes GYN and Urological/Prostate; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

["] Coded Pulse is for digitally encoded harmonics

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with 12S-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	Doppler Modes				CombinedModes*	HarmonicImaging	CodedPulse	Other
			PW	CW	Color	Color M	Power
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	p1	p1	p1	p1	p1	p1	p1	p1	p1	p1	[8]
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	p4	p4	p4	p4	p4	p4	N	p4	p4		[8]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial	p3	p3	p3	p3	p3	p3	p3	p3	p3
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/FluidDrainage[4]
Vascular Access[7]
Non-vascular access

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by

FDA K160078

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[*] Coded Pulse is for digitally encoded harmonics

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

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

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with LK760-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	CombinedModes*	HarmonicImaging	CodedPulse	Other
Anatomy/Region of Interest
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	p2		p2		p2		p2	p2	p2	N
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid
Drainage[4]
Vascular Access[7]
Non-vascular access

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics

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

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

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.

Diagnostic Ultrasound Indications for Use Form

Versana Premier with RIC5-9A-RS Transducer

Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:

Clinical Application	Mode of Operation							Other
	B	M	Doppler Modes		Color	Color M	Power
Anatomy/Region of Interest			PW	CW
Ophthalmic
Fetal / Obstetrics	p1	p1	p1		p1		p1	[5][8]
Abdominal[1]	p1	p1	p1		p1		p1	[5][8]
Pediatric
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Thoracic/Pleural
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal	N		N		N		N
Transvaginal	p1		p1		p1		p1
Intraoperative
Interventional Guidance
Tissue Biopsy/Fluid Drainage[4]	N				N	N	N
Vascular Access[7]
Non-vascular access

N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;

P = previously cleared by FDA K151028; P = previously cleared by FDA K161706, P P = previously cleared by FDA K160078

Notes: [1] Abdominal includes GYN and Urological/Prostate;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac includes Adult and Pediatric;

[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide

[5] 3D/4D imaging Mode

[6] Elastography imaging-Elasticity

[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;

[8] Image guidance for freehand needle/catheter placement;

[*] Combined modes are B/M, B/ Color M, B/PWD, B/Color/PWD, B/Power/PWD;

[*] Coded Pulse is for digitally encoded harmonics

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

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

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

Date:	August 17, 2018
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120tracey.ortiz@ge.com
Secondary Contact Person:	Gao GanRegulatory AffairsGE Healthcare
Device Trade Name:	Versana Premier
Common/Usual Name:	Diagnostic Ultrasound System
Classification Names:	Class II
Product Code:	IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX
Primary Predicate Device:	LOGIQ F8 Expert (K160277)
Secondary Predicate Device(s):	LOGIQ P9 (K163596)LOGIQ e (K151028)Vscan Extend (K180995)Predicates used only for changes to transducer applications:Vivid iq (K161706) and Vivid T8 (K160078)
Device Description:	The Versana Premier is a general purpose, diagnostic ultrasoundsystem for use by qualified healthcare professionals. The systemconsists of a mobile console, operator control panel, displaymonitor and some transducers.The console provides digital acquisition, processing and displaycapability. The system has an internal battery to allow foracquisition while the system is not plugged into a power source.The operator control panel includes an ultrasound keyboard,trackball, an alfa-numeric keyboard and a touch panel as inputsources of the device.

Image /page/19/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular frame, and the entire logo is colored in a shade of blue.

K182277

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

Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The blue circle has a swirling pattern around the letters, giving the logo a dynamic and recognizable appearance.

The variety of transducers include convex, linear, sector and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial. Intended Use: The Versana Premier are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Peripheral Vascular, Musculos-keletal Conventional, Musculos-keletal Superficial, Transcranial, Transrectal, Transvaginal, Tissue Biopsy/Fluid Drainage.

Technology: The Versana Premier employs the same fundamental scientific technology as its predicate devices.

Determination of Comparison to Predicate Devices Substantial Equivalence:

The Versana Premier system is a new platform substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed Versana Premier and the predicates LOGIQ F8 Expert (K160277). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.

. The Versana Premier and predicate LOGIQ F8 Expert (K160277) have same clinical indications for use.
The Versana Premier and predicate LOGIQ F8 Expert ● (K160277) have similar imaging modes.
The Versana Premier and predicate LOGIO F8 Expert . (K160277) systems transducers are similar. Coded Pulse mode is added to 8C-RS, E8C-RS, RAB2-6-RS, E8Cs-RS transducers. Non-vascular access application is added to 4C-RS transducer. Vascular access and Non-vascular access are added to L6-12-RS transducer. The RIC5-9A-RS transducer is added to Versana Premier which was cleared in LOGIQ P9 (K163596) andhe applications of Transrectal, Tissue Biopsy/Fluid Drainage are being added. The Versana Premier includes the 12L-RS transducer which was cleared in LOGIO P9 (K163596) however Coded Pulse mode and Non-vascular access are being added. The Versana Premier includes the LK760-RS transducer which was cleared in LOGIQ e (K151028) and Coded Pulse mode is being added. The Versana Premier includes the 12S-RS transducer which was

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

Image /page/21/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 color of the logo is a light blue.

GE Healthcare

510(k) Premarket Notification Submission

cleared in LOGIO P9 (K163596) and Power Doppler Imaging mode is being added. The applications of Cardiac is being added per Vivid T8 (K160078) and Transcranial is being added per Vivid iq (K161706) to the 12S-RS.

Features added from LOGIQ P9 (K163596): Vocal, . Breast Productivity, Thyroid productivity, Tissue Velocity M Mode image (TVM).
. Features added from LOGIQ e (K151028): Needle recognition and Follow-Up tool.
. Features added from Vscan Extend (180995): Auto Bladder Volume and Tricefy Uplink.
Adding new features called Breast Care 2.0 and Whizz.
Adding some new hardware ●
The Versana Premier and predicate LOGIO F8 Expert ● (K160277) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The system is manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
. The system has acoustic power levels which are below the applicable FDA limits.
The Versana Premier and predicate LOGIO F8 Expert ● (K160277) have been designed in compliance with approved electrical and physical safety standards.

Summary of Non-Clinical Tests:

Versana Premier 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 comply with applicable medical device safety standards. The Versana Premier complies with voluntary standards:

AAMI/ANSI ES60601-1, Medical Electrical Equipment -. Part 1: General requirements for basic safety and essential performance - 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
IEC60601-1-2, Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic

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

Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.

GE Healthcare

510(k) Premarket Notification Submission

disturbances - Requirements and tests - Edition 4.0 2014-02

IEC60601-2-37, Medical electrical equipment Part 2-37: . Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - Edition 2.1 2015
ISO10993-1, Biological evaluation of medical devices -● Part 1: Evaluation and testing within a risk management process - Fourth edition 2009-10-15
NEMA UD 2, Acoustic Output Measurement Standard for . Diagnostic Ultrasound Equipment - revisions 3 - 2004 (R2009)
ISO14971, Application of risk management to medical . devices, 2007
NEMA PS 3.1 3.20, Digital Imaging and . Communications in Medicine (DICOM) Set - 3.1 - 3.20 (2016)

The following quality assurance measures are applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification) ●
Integration testing (System verification) ●
Performance testing (Verification) .
Safety testing (Verification) ●

Transducer material and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Versana Premier to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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.