The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
Fluid Visualization.
2D / 3D Imaging
MR Angiography / MR Vascular Imaging.
Blood Oxygenation Level Dependent (BOLD) imaging
Perfusion / Diffusion Imaging.
Proton Spectroscopy.

Device Description

The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.

The maximum gradient strength and the maximum slew rate have been increased.
The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz.
SAR 1st level operating mode as specified in IEC 60601-2-33 (2002).
The performance (Min.TR/Min.TE / Min.Slice thickness) of a sequence has been improved.

AI/ML Overview

The provided text describes specific features and safety parameters of a Magnetic Resonance Diagnostic Device Accessory (MRT-1503/P5, EXCELART Vantage™ ZGV) and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving those criteria were met, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.

The document is a 510(k) summary for a submission to the FDA, primarily focused on demonstrating "substantial equivalence" to a previously cleared device (EXCELART Vantage™ XGV/AGV, K032490). The changes highlighted are hardware and software modifications that improve performance or allow for access to specific operating modes, but these are not presented as acceptance criteria against specific performance metrics (e.g., sensitivity, specificity for a diagnostic task).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria or a study proving their fulfillment from the provided text.

The document states:

"IMAGING PERFORMANCE PARAMETERS: No changes from the previous submission, K032490." This implies that the imaging performance is expected to be the same as the predicate device, but it doesn't detail what those performance parameters are or how they were assessed.
"TOSHIBA Medical Systems Corporation believes that the new EXCELART Vantage™ ZGV (model MRT-1503/P5) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) (K032490 ) cleared on August 21, 2003." This is the core argument for clearance, not a report of a specific study proving the new device's performance against defined acceptance criteria.

The FDA's letter confirms the substantial equivalence determination based on the indications for use.

To answer your request, a different type of document, such as a clinical validation report or a detailed performance specification document, would be needed.

Summary

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JAN 1 8 2006

06 0003

Appendix 1

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. DEVICE NAME:	Magnetic Resonance Diagnostic Device Accessory
Model Name:	MRT-1503/P5
Trade/Proprietary Name:	EXCELART Vantage™ ZGV
2. ESTABLISHMENT REGISTRATION:	2020563

TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 3. U.S. Agent Name and Address: 2441 MICHELLE DRIVE TUSTIN, CA 92780

Paul Biggins Contact Person: (714) 730 - 5000

TOSHIBA CORPORATION Manufacturing Site: 4. MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
December 22, 2005 DATE OF SUBMISSION: 5.

DEVICE DESCRIPTION 6.

The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.

The maximum gradient strength and the maximum slew rate have been increased. .
The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz. ,
SAR 1st level operating mode as specified in IEC 60601-2-33 (2002). .
Thel performance (Min.TR/Min.TE / Min.Slice thickness ) of a sequence has been , improved.

Model Number with suffix	Trade/Proprietary Name
MRT-1503/P5	EXCELART Vantage™ ZGV

6.1. SUMMARY OF MAJOR HARDWARE CHANGES

A. The gradient coil was changed for higher gradient strength and slew rate .
B. The gradient power supply was changed for higher gradient strength and slew rate.
C: The clock of CPU was changed from 2.8GHz to 3.2GHz.
D. Flex coils (70, 100, 150, 200mm, Rectangular) are added to the available coil list.
E. QD Knee/Foot coil ( K051763) is added.

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6.2. SUMMARY OF MAJOR SOFTWARE CHANGES

A. New CPU correspondence.
B. New RF coil control.
C. SAR limitation control.

7. SAFETY PARAMETERS

	Current EXCELARTVantage™ XGV/AGV (Nochanges from the previoussubmission, K032490 )	New EXCELARTVantage™ ZGV
a. Static field strength:	1.5 T	Same
b. Peak and A-weightedacoustic noise:	110 dB (A-weighted)	Same
c. Operational modes:	1st operating mode for dB/dt	1st operating modefor dB/dt and SAR
i. Safety parameter display:	SAR, dB/dt	Same
ii. Operating mode accessrequirements:	Not applicable because usedonly in normal operatingmode	Allows access to 1stlevel operating mode
d. Maximum SAR	Normal operating modespecified in IEC 60601-2-33(2002)	1st operating modespecified in IEC60601-2-33 (2002)
e. Maximum dB/dt	<1st operating mode specifiedin IEC 60601-2-33 (2002)	Same
and Gradient coil dimensions:	692 x 893 x 1405(unit: mm)	Same
f. Potential emergencyconditions and means providedfor shutdown:	Shut down by EmergencyRamp Down Unit for collisionhazard by ferromagneticobjects	Same
g. Biocompatibility of materials:	Not applicable	Same

IMAGING PERFORMANCE PARAMETERS 8.

No changes from the previous submission, K032490 .

9. INTENDED USE

No changes from the previous submission, K032490 .

10. EQUIVALENCY INFORMATION

TOSHIBA Medical Systems Corporation believes that the new EXCELART Vantage™ ZGV (model MRT-1503/P5) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) (K032490 ) cleared on August 21, 2003.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2006

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K060003 Trade/Device Name: Excelart Vantage™ ZGV Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 29, 2005 Received: January 3, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brigdon

Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

Indications for Use

510(k) Number (if known):

Device Name: EXCELART Vantage™ ZGV

Indications for Use:

Imaging of:

The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, t t neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
Fluid Visualization .
. 2D / 3D Imaging
MR Angiography / MR Vascular Imaging .
Blood Oxygenation Level Dependent (BOLD) imaging ●
Perfusion / Diffusion Imaging .
Proton Spectroscopy .

Prescription Use
(Part 21 CFR 801Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Seymour

(Division Sign-Off) Division of Reproductive, Abdon and Parlicipal Devices 510K, NUMBER ______________

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.