EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2

K023511 · Toshiba America Medical Systems, In.C · LNH · Nov 5, 2002 · Radiology

Device Facts

• Record ID: K023511
• Device Name: EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LNH · Radiology
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Imaging of: - 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 Myelography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { K002531 } - Fluid Visualization { K002531 } ● - 2D / 3D Imaging { K002531} - MR Angiography / MR Vascular Imaging {K002531} - Blood Oxygenation Level Dependent (BOLD) imaging { K002531} ● - Perfusion / Diffusion Imaging {K993803, K002531} - Proton Spectroscopy { K010129}

Device Story

EXCELART™ with Pianissimo XG/AG SPIN Edition is a 1.5T MRI system. Inputs include RF signals from patient anatomy via various RF coils (e.g., QD Torso SPEEDER, 8ch phased array, 70mm circular coil). System transforms signals into diagnostic images using high-speed reconstruction computer. Features include True Steady State Free Precession (SSFP) sequence, parallel imaging, and redesigned gating unit for improved sequence triggering. Operated by trained clinicians in clinical settings. Output is diagnostic MR imagery used for clinical decision-making across whole-body applications. Benefits include reduced scan times via parallel imaging and improved image processing speeds. Safety features include dB/dt limitation control (1st operating mode) and emergency ramp-down unit.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance parameters (static field strength, SAR, acoustic noise, gradient dimensions) compared against predicate to demonstrate equivalence.

Technological Characteristics

1.5T MRI system. Materials: standard medical-grade components. Energy: RF and magnetic gradient fields. Connectivity: Standalone system. Software: Improved UI, RF coil control, dB/dt limitation control, True SSFP sequence, parallel imaging. Gradient coil dimensions: 1050 x 1175 x 50 mm. Max dB/dt: 46 T/sec.

Indications for Use

Indicated for whole-body MRI imaging, including head, abdomen, pelvis, limbs, spine, neck, TMJ, heart, and vasculature. Supports specialized applications like MRCP, MR fluoroscopy, BOLD, perfusion/diffusion, and proton spectroscopy. No specific age or gender restrictions noted.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• EXCELART™ with Pianissimo XG/AG (K002531)

Reference Devices

• QD Neurovascular array coil (K001870)
• K993803
• K010129

Submission Summary (Full Text)

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ਤੇ ਨੇ ।।

5 2002 NOV

Appendix 1

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|
| Model Name: | MRT-1501/P3,P2 |
| Trade/Proprietary Name: | EXCELART™ with Pianissimo XG/AG SPIN Edition |
| 2. ESTABLISHMENT REGISTRATION: | 2020563 |
| 3. U.S. Agent Name and Address: | TOSHIBA AMERICA MEDICAL SYSTEMS, INC.<br>2441 MICHELLE DRIVE<br>TUSTIN, CA 92780 |
| Contact Person: | Michaela Mahl<br>(714) 730 - 5000 |
| 4. Manufacturing Site: | TOSHIBA CORPORATION<br>MEDICAL SYSTEMS COMPANY<br>1385 Shimoishigami<br>Otawara-shi, Tochigi 324-8550, Japan |
| 5. DATE OF SUBMISSION: | September 27, 2002 |

#### DEVICE DESCRIPTION 6.

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

- Extension of a receiving system is enabled a maximum of 8 ch. .
- Use of QD Torso SPEEDER corresponding to Parallel imaging which can shorten scan time is . enabled.
- The computer only for reconstruction was carried for high-speed image processing. .
- . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33 by the TrueSSFP sequence.
- Max. field strength is changed 25mT/m to 30mT/m. .
- . The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a sequence has been improved.
- The user interface of software was changed for the improvement of operativity. '
- . Gating unit was redesigned to improve the making triggers for sequence.

| Model Number with suffix | Trade/Proprietary Name |
|--------------------------|--------------------------------------------------------|
| MRT-1501/P3 | EXCELART ^TM with Pianissimo XG SPIN Edition |
| MRT-1501/P2 | EXCELART ^TM with Pianissimo AG SPIN Edition |

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#### SUMMARY OF MAJOR HARDWARE CHANGES 6.1.

A. The computer only for reconstruction was carried for high-speed image processing.

- B. Gating unit was redesigned to improve the making triggers for sequence.
C: 8ch phased array kit is added in the optional items.

D. 70mm Circular coil is added in the optional items.

E. QD torso SPEEDER is added in the optional items.

F. QD Neurovascular array coil (K001870) is added in the optional items.

#### SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.

A. Improved user interface.

- B. New RF coils control.
- C. dB/dt limitation control.
- D. True Steady State Free Precession (SSFP) sequence.
- E. Parallel imaging.

#### 7. SAFETY PARAMETERS

| | Current EXCELART™ with<br>Pianissimo XG/AG (No changes<br>from the previous submission,<br>K002531) | New EXCELART™<br>with Pianissimo<br>XG/AG SPIN Edition |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted acoustic<br>noise: | 95.0 dB(A-weighted) | 95.4 dB(A-weighted) |
| c. Operational modes: | Normal operating mode | 1st operating mode for<br>dB/dt |
| i. Safety parameter display: | SAR | SAR, dB/dt |
| ii. Operating mode access<br>requirements: | Not applicable because used<br>only in normal operating mode | Same |
| d. Maximum SAR | < 1.5 W/kg | Same |
| e. Maximum dB/dt<br>and Gradient coil dimensions: | 19.3T/sec<br>1050 x 1175 x 51<br>(unit: mm) | 46 T/sec<br>1050 x 1175 x 50<br>(unit: mm) |
| f. Potential emergency conditions<br>and means provided for shutdown: | Shut down by Emergency Ramp<br>Down Unit for collision hazard<br>by ferromagnetic objects | Same |
| g. Biocompatibility of materials: | Not applicable | Same |

#### IMAGING PERFORMANCE PARAMETERS 8.

No changes from the previous submission, K002531.

#### 9. INTENDED USE

No changes from the previous submission, K002531.

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## 10. EQUIVAALENCY INFORMATION

TOSHIBA Corporation Medical Systems Company believes that the new EXCELART™ with Pianissimo XG/AG SPIN Edition (model MRT-1501/P3, MRT-1501/P2) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART™ with Pianissimo XG/AG (model MRT-1501/P3, MRT-1501/P2) (K002531) cleared on October 26, 2000 except for new RF coils and dB/dt limitation.

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Image /page/3/Picture/1 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT of HEALTH & HUMAN SERVICES" are arranged vertically along the left side of the logo in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 NOV

Toshiba America Medical Systems, Inc. % Mr. Mark Job 510(k) Program Manager TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112 Re: K023511

Trade/Device Name: EXCELART™ with Pianissimo XG, AG SPIN Edition Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH

Dated: October 17, 2002 Received: October 21, 2002

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 (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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Snigdon

Nancy 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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Page 1

KO2 35 11 510(k) Number (if known).

Device Name: EXCELART™ with Pianissimo XG, AG SPIN Edition

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 Cholangiopancreatography), MR Cisternography, MR Myelography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { K002531 }
- Fluid Visualization { K002531 } ●
- . 2D / 3D Imaging { K002531}
- . MR Angiography / MR Vascular Imaging {K002531}
- Blood Oxygenation Level Dependent (BOLD) imaging { K002531} ●
- Perfusion / Diffusion Imaging {K993803, K002531}
- . Proton Spectroscopy { K010129}

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR -

】【

Over-The-Counter Use

(Optional Format 1-2-96)

.

(Division Sign Off)
Division: Digestive, Abdominal,
and GI Devices