The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholanqiopancreatography), 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™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.

New gantry design as Ultra-short bore. .
. New patient couch design as wide couch top.
It is possible to combine detachable couch top and gurney of exclusive use. .
. The CPU of computer system was changed from RISC type to Xeon.
. dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
. SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
The gating waveform can be displayed by the side of the gantry. .

AI/ML Overview

This document describes a 510(k) submission for the EXCELART Vantage™ XGV/AGV MRI system. The submission focuses on demonstrating substantial equivalence to a predicate device, the EXCELART™ with Pianissimo XG/AG SPIN Edition.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on comparing the safety and imaging performance parameters of the new device to its predicate. The acceptance criteria essentially align with maintaining or improving upon the predicate device's specifications, particularly within regulated safety limits.

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (New Device)
Safety Parameters
Static field strength	1.5 T	Same (1.5 T)
Peak & A-weighted acoustic noise	95.4 dB (A-weighted)	110 dB (A-weighted)
Operational modes	1st operating mode for dB/dt, SAR, dB/dt	Same
Safety parameter display	Same	Same
Operating mode access requirements	Not applicable (used only in normal operating mode)	Same
Maximum SAR	< 1.5 W/kg	< 2.0 W/kg
Maximum dB/dt	46 T/sec	<1st operating mode specified in IEC 60601-2-33 (2002)
Gradient coil dimensions	1050 x 1175 x 50 (unit: mm)	692 x 893 x 1405 (unit: mm)
Emergency conditions/shutdown	Shut down by Emergency Ramp Down Unit for collision hazard by ferromagnetic objects	Same
Biocompatibility of materials	Not applicable	Same
Imaging Performance Parameters	No changes from previous submission (K023511)	No changes from previous submission (K023511)

Notes on the table:

Acoustic Noise: The new device reports a higher acoustic noise (110 dB) compared to the predicate (95.4 dB). While this is a change, it's presented within the context of substantial equivalence, implying it still meets regulatory limits or is otherwise deemed acceptable. MRI systems can have varying acoustic noise levels depending on gradient strength, pulse sequences, and patient comfort features.
Maximum SAR: The new device allows for a higher maximum SAR (< 2.0 W/kg) compared to the predicate (< 1.5 W/kg). This is explicitly stated as being in compliance with IEC 60601-2-33 (2002).
Maximum dB/dt: The new device specifies "<1st operating mode specified in IEC 60601-2-33 (2002)," indicating compliance with international safety standards, which may differ from the numerical value of the predicate.
Gradient coil dimensions: The dimensions have changed, which is expected with a "short bore" magnet system. This is a design change rather than a performance criterion for acceptance.
Imaging Performance: The document explicitly states "No changes from the previous submission, K023511," for imaging performance, implying that the new device's imaging capabilities are at least equivalent to the predicate.

2. Sample size used for the test set and the data provenance

The document does not provide details on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the device's clinical performance. This is because the submission is for an MRI system, not a diagnostic algorithm or a device that directly measures a clinical outcome through data analysis. The "study" here refers to the engineering and regulatory review demonstrating that the new MRI system meets safety and performance specifications relative to its predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, this submission is for an MRI system, and does not involve clinical data analysis requiring expert-established ground truth for a test set. The "ground truth" for the device's technical performance is established through engineering specifications, international safety standards (like IEC 60601-2-33), and comparison to the predicate device's cleared specifications.

4. Adjudication method for the test set

Not applicable, as there is no mention of a test set requiring adjudication in this 510(k) summary.

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. This document pertains to an MRI scanner system, not an AI-powered diagnostic tool. Therefore, MRMC studies evaluating human reader performance with or without AI assistance are not relevant to this submission.

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

Not applicable. This is not for a standalone algorithm.

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

The ground truth for the performance evaluation in this 510(k) submission is primarily based on:

Engineering Specifications: Adherence to defined technical parameters (e.g., field strength, gradient coil characteristics).
International Safety Standards: Compliance with standards like IEC 60601-2-33 (2002) for SAR and dB/dt limitations.
Predicate Device Equivalence: The performance and safety characteristics of the new device are measured against the legally marketed and cleared predicate device (K023511).

8. The sample size for the training set

Not applicable. This submission concerns hardware and software modifications to an MRI system, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.

Summary

{0}------------------------------------------------

AUG 2 1 2003

Page 1 of 2

Appendix 1

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. DEVICE NAME:	Magnetic Resonance Diagnostic Device Accessory
Model Name:	MRT-1503/P3, P2
Trade/Proprietary Name:	EXCELART Vantage ™ XGV/AGV

1. ESTABLISHMENT REGISTRATION: 2020563
  TOSHIBA AMERICA MEDICAL SYSTEMS,INC. U.S. Agent Name and Address: 2441 MICHELLE DRIVE

TUSTIN, CA 92780

Michaela Mahl (714) 730 - 5000

Contact Person:

Manufacturing Site: TOSHIBA CORPORATION 4. MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

1. DATE OF SUBMISSION: July 11, 2003

6. DEVICE DESCRIPTION

The EXCELART Vantage™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.

New gantry design as Ultra-short bore. .
. New patient couch design as wide couch top.
It is possible to combine detachable couch top and gurney of exclusive use. .
. The CPU of computer system was changed from RISC type to Xeon.
. dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
. SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
The gating waveform can be displayed by the side of the gantry. .

Model Number with suffix	Trade/Proprietary Name
MRT-1503/P3	EXCELART Vantage™ XGV
MRT-1503/P2	EXCELART Vantage™ AGV

{1}------------------------------------------------

K032490
Page 2 of 2

Appendix 1

6.1. SUMMARY OF MAJOR HARDWARE CHANGES

A. The magnet system was changed to short bore.

B. The gradient coil was changed to short bore.

C: The patient couch was changed to wide and detachable couch top.

D. It is possible to combine detachable couch top and gurney of exclusive use.

E. The whole body coil was modified for corresponds to SAR 2.0w/kg

F. 4ch flex body array coil is added in the optional items.

G. QD head SPEEDER (K022582) is added in the optional items.

H. The gating waveform can be displayed by the side of the gantry

6.2. SUMMARY OF MAJOR SOFTWARE CHANGES

A. New CPU correspondence.
B. New RF coils control.
C. dB/dt limitation control.
D. SAR limitation control.

7. SAFETY PARAMETERS

	Current EXCELART™ withPianissimo XG/AG SPINEdition (No changes from theprevious submission,K023511 )	New EXCELART™Vantage™XGV/AGV
a. Static field strength:	1.5 T	Same
b. Peak and A-weightedacoustic noise:	95.4 dB (A-weighted)	110 dB (A-weighted)
c. Operational modes:	1st operating mode for dB/dtSAR, dB/dt	Same
i. Safety parameter display:	Same	Same
ii. Operating mode accessrequirements:	Not applicable because usedonly in normal operatingmode	Same
d. Maximum SAR	< 1.5 W/kg	< 2.0 W/kg
e. Maximum dB/dt	46 T/sec	<1st operating modespecified in IEC60601-2-33 (2002)
and Gradient coil dimensions:	1050 x 1175 x 50(unit: mm)	692 x 893 x 1405(unit: mm)
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

{2}------------------------------------------------

8. IMAGING PERFORMANCE PARAMETERS

No changes from the previous submission, K023511 .

9. INTENDED USE

No changes from the previous submission, K023511 .

10. EQUIVAALENCY INFORMATION

TOSHIBA Corporation Medical Systems Company believes that the new EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART™ with Pianissimo XG/AG SPIN Edition (model MRT-1501/P3, MRT-1501/P2) (K023511 ) cleared on November 05, 2002 except for new gantry and patient couch, new RF coils and dB/dt, SAR limitation.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

Toshiba America Medical Systems, Inc. % Ms. Laura Danielson Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K032490

Trade/Device Name: Excelart Vantage™ XGV/AGV Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: August 11, 2003 Received: August 12, 2003

Dear Ms. Danielson:

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 (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); 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.

{4}------------------------------------------------

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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

{5}------------------------------------------------

Attachment I

Page 1____ of ________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):	K1632490
---------------------------	----------

Device Name: EXCELART Vantage™ XGV/AGV

Indications for Use:

Imaging of:

The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholanqiopancreatography), 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 .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

Ohmil A. Sypon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number_

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.