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 Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.

The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.

Gantry bore diameter has been increased from 600mm to 690mm at bore center.
Maximum power of RF amplifier has been increased from 20KW to 35KW.
RF amplifier cabinet has been added.
Gradient power supply has been modified to increase the output current from 300A to 550A.
Transformer cabinet has been modified to cover the system power requirement.

AI/ML Overview

The provided 510(k) Premarket Notification for the Toshiba Vantage Titan MR system (K080038) does not describe acceptance criteria or a study proving that the device meets those criteria in the context of device performance regarding image quality or clinical efficacy.

Instead, this submission is centered around demonstrating substantial equivalence to a previously cleared predicate device (EXCELART Vantage Atlas-X, K063361), following modifications to hardware and software. The primary focus is on ensuring that the modifications do not alter the system's safety parameters or intended use, and that imaging performance remains equivalent to the predicate.

Here's a breakdown of the requested information based on the provided document:

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

Acceptance Criteria Category	Specific Criteria (from predicate K063361, assumed to be met by Vantage Titan)	Reported Device Performance (Vantage Titan)
Safety Parameters
Static field strength	1.5 T	Same (1.5 T)
Peak and A-weighted acoustic noise	110 dB (A-weighted)	Same (110 dB)
Operational modes	1st operating mode for dB/dt and SAR	Same (1st operating mode)
Safety parameter display	SAR, dB/dt	Same (SAR, dB/dt)
Operating mode access requirements	Allows access to 1st level operating mode	Same (allows access to 1st level operating mode)
Maximum SAR	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2002))	Same (4W/kg for whole body)
Maximum dB/dt	<1st operating mode specified in IEC 60601-2-33 (2002)	Same (<1st operating mode)
Gradient coil dimensions	692 x 893 x 1405 (unit: mm)	760 x 893 x 1405 (unit: mm) - Modified
Potential emergency conditions and means for shutdown	Shut down by Emergency Ramp Down Unit for collision hazard by ferromagnetic objects	Same (Shut down by Emergency Ramp Down Unit)
Biocompatibility of materials	Not applicable	Same (Not applicable)
Imaging Performance Parameters	No changes from previous submission, K063361.	No changes from previous submission, K063361 (i.e., equivalent to predicate)

Important Note: The document explicitly states "IMAGING PERFORMANCE PARAMETERS: No changes from the previous submission, K063361." This means that detailed performance metrics (like signal-to-noise ratio, resolution, contrast, etc.) are not provided nor are specific acceptance criteria for these listed in this document. The submission relies on the predicate device (K063361) having already met such imaging performance criteria, and the modifications in K080038 are deemed not to negatively impact them.

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

This information is not provided in the document. As this is a 510(k) submission focused on substantial equivalence through hardware and software modifications, rather than a de novo device or a system with new clinical indications, a specific clinical "test set" study for image quality or diagnostic accuracy is not discussed. The evaluation likely involved engineering tests and comparisons between the modified system and the predicate, but these details are not provided.

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)

This information is not provided. No "test set" in the context of expert ground truth is described.

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

This information is not provided.

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

No MRMC comparative effectiveness study was done as described in this document. This submission is for a general-purpose MRI system, not an AI-powered diagnostic tool.

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

Not applicable. This submission is for an MRI system, not a standalone algorithm.

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

This information is not provided. Given the nature of the submission (demonstrating equivalence for an MRI system), "ground truth" would likely relate to objective physical measurements of image quality, system performance (e.g., field homogeneity, gradient linearity), and safety parameters, compared against the predicate and established standards (like IEC 60601-2-33). These details are not elaborated upon in this summary document.

8. The sample size for the training set

This information is not provided. MRI system design and engineering do not typically involve "training sets" in the sense of machine learning algorithms.

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

Not applicable. No training set for an algorithm is discussed.

In summary:

This 510(k) document is a declaration of substantial equivalence for a modified MRI system. It focuses on ensuring that changes to hardware and software do not negatively impact the device's safety or imaging performance, which is implicitly assumed to be equivalent to the predicate device (K063361). Therefore, it does not contain the detailed clinical study information typically seen for novel diagnostic devices or AI-driven systems. The "proof" relies on the assertion that the modifications are minor and that safety and performance equivalence to the predicate (which was previously cleared) has been maintained.

Summary

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Toshiba America Medical Systems, Inc.

K080038
pg 1 of 3
510(k) Premarket Notification
Vantage Titan
TM

JAN 22 2008

510(k) SUMMARY

DEVICE NAME:

Model Name:

Trade/Proprietary Name:

Magnetic Resonance Diagnostic Device Accessory MRT-1504/S3 Vantage Titan

2. ESTABLISHMENT REGISTRATION: 2020563

3. U.S. Agent Name and Address:	Toshiba America Medical Systems, Inc.2441 Michelle DriveTustin, Ca 92780
Contact Person:	Paul Biggins(714) 730 - 5000

TOSHIBA CORPORATION MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

5. DATE OF SUBMISSION: December 19, 2007

6. DEVICE DESCRIPTION

Manufacturing Site:

The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.

· Gantry bore diameter has been increased from 600mm to 690mm at bore center.
· Maximum power of RF amplifier has been increased from 20KW to 35KW.
· RF amplifier cabinet has been added.
· Gradient power supply has been modified to increase the output current from 300A to 550A.
· Transformer cabinet has been modified to cover the system power requirement.

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K080038
pg. 2 of 3

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Vantage TitanTM

6.1. SUMMARY OF MAJOR HARDWARE CHANGES

a. Gradient coil has been modified to increased the inside diameter.
b. WB coil has been modified to increased the inside diameter.
Maximum power of RF amplifier has been increased from 20KW to 35KW. C.
d. RF amplifier cabinet has been added.
Gradient power supply has been modified to increase the output current from 300A to e. 550A.
f. Transformer cabinet has been modified to cover the system power requirement.

SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.

a. New RF amplifier cabinet control.
b. New gradient power supply control.
C. Add the over temperature protection inside the gantry bore.
d. Modified the data base for distortion correction for new gradient coil.
e. Modified the data base for SAR control for new WB coil.

	Current EXCELART VantageAtlas-X (No changes from theprevious submission, K063361 )	New Vantage Titan
a. Static field strength:	1.5 T	Same
b. Peak and A-weighted acousticnoise:	110 dB (A-weighted)	Same
c. Operational modes:	1st operating mode for dB/dt andSAR	Same
i. Safety parameter display:	SAR, dB/dt	Same
ii. Operating mode accessrequirements:	Allows access to 1st level operatingmode	Same
d. Maximum SAR	4W/kg for whole body (1stoperating mode specified in IEC60601-2-33 (2002))	Same
f. Maximum dB/dt	<1st operating mode specified inIEC 60601-2-33 (2002)	Same
and Gradient coil dimensions:	692 x 893 x 1405(unit: mm)	760 x 893 x 1405(unit: mm)
f. Potential emergency conditionsand means provided forshutdown:	Shut down by Emergency RampDown Unit for collision hazard byferromagnetic objects	Same
g. Biocompatibility of materials:	Not applicable	Same

7. SAFETY PARAMETERS

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K080038
pg. 3 of 3

Toshiba America Medical Systems, Inc.

510(k) Premarket Notification Vantage TitanTM

IMAGING PERFORMANCE PARAMETERS 8.

No changes from the previous submission, K063361.

INTENDED USE 9.

No changes from the previous submission, K063361.

10. EQUIVALENCY INFORMATION

Toshiba Medical Systems Corporation believes that the new Vantage Titan (model MRT-1504/S3) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage Atlas-X (model MRT-1503/S3) (K063361) cleared on November 21, 2006.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 22 2008

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

Re: K080038

Trade/Device Name: Vantage Titan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 4, 2008 Received: January 7, 2008

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, 1796, 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 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.

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Page 2

Enclosure

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.

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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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

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Indications for Use

510(k) Number (if known):

Device Name: Vantage Titan_

Indications for Use:

Imaging of:

The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, 0 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 G
. Proton Spectroscopy

Prescription Use (Part 21 CFR 801Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) 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.