The MRI system is indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

. Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1) .
. Spin-spin relaxation time (T2)
Flow dynamics .
Chemical shift .

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Device Description

The Vantage Titan HSR (Model MRT-1504/A5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan HSR uses the same magnet as the existing Vantage Titan (K080038). It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan HSR provides the maximum field of view of 55 x 55 x 55 cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Toshiba Vantage Titan HSR MRI system, focusing on its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, device performance metrics, or a study designed to prove the device meets these criteria in the manner requested.

The document details safety parameters and imaging performance but only states:

Imaging Performance Parameters: "No change from the previous predicate submission (K080038)."
Testing: "Testing was done in accordance with applicable recognized consensus standards as listed below. Additionally, human volunteer studies (in Japan) were conducted to verify imaging performance."

This indicates that the primary method for demonstrating device effectiveness and safety was through showing substantial equivalence to an existing device, rather than through a new, specific performance study with defined acceptance criteria. The "human volunteer studies" are mentioned very generally without details on design, metrics, or results.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance through substantial equivalence, hardware/software changes, and safety standards, not on a detailed clinical or performance study with acceptance criteria and results.

Summary

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

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan HSR, MRT-1504/A5

510(k) SUMMARY AND EFFECTIVENESS

1. DEVICE NAME:

Generic Name:	Magnetic Resonance Diagnostic Device
Model Name:	MRT-1504/A5
Trade/ Proprietary Name:	Vantage Titan HSR

2. ESTABLISHMENT REGISTRATION: 2020563

3. U.S AGENT INFORMATION:

U.S. Agent Name:	Paul Biggins(714) 730-5000
Establishment Name and Address:	Toshiba America Medical Systems, Inc.2441 Michelle DriveTustin, Ca. 92780
4. MANUFACTURING SITE:	Toshiba Medical Systems Corporation1385 ShimoishigamiOtawara-shi, Tochigi 324-8550Japan
5. DATE OF SUBMISSION:	November 14, 2011

6. DEVICE DESCRIPTION:

7. SUMMARY OF MAJOR HARDWARE CHANGES

a. New Gradient amplifier
b. New Gradient coil
c. Wireless gating unit is added (optional)

Page 1 of 4

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

8. SUMMARY OF MAJOR SOFTWARE CHANGES

a. New Software platform
b. Modified the data base for distribution correction and dB/dt calculation for new gradient coil.

9. SAFETY PARAMETERS

Item	New Vantage Titan HSR(Subject device)	EXCELART VantageTitan , K080038(Predicate Device)	Notes
Static field strength	1.5T	1.5T	Same
Peak and A-weighted acousticnoise	113.0 dB (A-weighted)121.6 dB (peak)	105.7 dB (A-weighted)115.7dB (peak)	Same
Operational Modes	1st Operating Mode	1st Operating Mode	Same
i. Safety parameterdisplay	SAR dB/dt	SAR dB/dt	Same
ii. Operating modeaccessrequirements	Allows screen access to1st level operating mode	Allows screen access to1st level operating mode	Same
Maximum SAR	4W/kg for whole body (1stoperating mode specifiedinIEC 60601-2-33(2002))	4W/kg for whole body (1stoperating mode specifiedinIEC 60601-2-33(2002))	Same
Maximum dB/dt	<1st operating modespecified inIEC 60601-2-33 (2002)	<1st operating modespecified inIEC 60601-2-33 (2002)	Same
Gradient coildimensions	760 x 893 x 1405(inner diameter x outerdiameter x length,unit = mm)	760 x 893 x 1405(inner diameter x outerdiameter x length,unit = mm)	Same
Potentialemergencycondition andmeans provided forshutdown	Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects	Shut down by EmergencyRamp Down Unit forcollision hazard forferromagnetic objects	Same
Biocompatibility ofmaterials	Confirmed for electrodesand accessories forwireless gating	Not applicable	Same

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

Image /page/2/Picture/0 description: The image shows the text "K112003" and "P3/4" in a large, bold font. Below this, the text "Toshiba America Medical Systems, Inc., Pre-Market Notification 510(k), Vantage Titan HSR, MRT-1504/A5" is printed in a smaller, regular font. The text appears to be part of a document or label, possibly related to medical equipment or regulatory information.

10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K080038).

11. INTEDED USE

The MRI system is indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and obligue images that display anatomic structures of the head or body. In addition, this system supports non-contrast MRA,

Proton density (PD) (also called hydrogen density) .
. Spin-lattice relaxation time (T1)
. Spin-spin relaxation time (T2)
Flow dynamics .
Chemical shift .

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

12. DESIGN CHANGE

The Vantage Titan HSR MRI System is comparable to the existing 1.5T Vantage Titan MRI System (K080038), with the following modifications.

a. Maximum gradient slew rate has been changed.
b. Power requirements have been changed.
c. CPU platform has been changed.

13. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software and hardware of changing unit have been completed and are attached. The test methods used are the same as those submitted in the previously cleared submissions (K0800338). A declaration of conformity with design controls is included in this submission.

14. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the Vantage Titan HSR described in this submission is provided in this submission.

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

Image /page/3/Picture/0 description: The image contains text that appears to be part of a document or label. The text indicates that it is related to Toshiba America Medical Systems, Inc. It also mentions "Pre-Market Notification 510(k)" and specifies "Vantage Titan HSR, MRT-1504/A5", which likely refers to a specific product or model.

15. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan HSR (model MRT-1504/A5) Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission.

Testing was done in accordance with applicable recognized consensus standards as listed below. Additionally, human volunteer studies (in Japan) were conducted to verify imaging performance.

List of Applicable Standards

IEC60601-1:1988, Amd.1:1991, Amd.2:1995
· IEC60601-1-1:2000
· IEC60601-1-2:2001, Amd.1:2004
· IEC60601-1-4:1996, Amd.1:1999
· IEC60601-1-6:2004
· IEC60601-1-8:2003,Amd.1:2006
IEC60601-2-33:2002, Amd.1:2005, Amd.2:2007
· IEC60825-1: 2007
· IEC62304:2006
· IEC62366:2007
· NEMA MS-1:2008
· NEMA MS-2:2003
· NEMA MS-3:2008
· NEMA MS-4:2006
· NEMA MS-5:2003
· NEMA PS 3.1-18 (2008)

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

Image /page/4/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation Mr. Paul Biggins Director Regulatory Affairs/U.S. Agent % Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K112003

Trade/Device Name: MRT-1504/A5, Vantage Titan HSR Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 14, 2011 Received: November 15, 2011

Dear Mr. Biggins:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

DEC - 2 2011

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan HSR, MRT-1504/A5

Indications for Use

510(k) Number (if known):

K112003

Device Name:

MRT-1504/A5, Vantage Titan HSR

Indications for Use:

. Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1) .
. Spin-spin relaxation time (T2)
Flow dynamics .
Chemical shift .

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Michael D'Ohm

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number_LLZOO O 3

Page 1 of

Indication for Use Page 1 of 1

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.