Who is the manufacturer of VISART?

Toshiba America Medical Systems, In.C filed the 510(k) submission for VISART (K961092).

What is the FDA product code for VISART?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for VISART?

510(k) clearance (submission type: Traditional).

What are the predicate devices for VISART?

MRT-150A (K903768A); Flexart™ (K933018); MRT-35A.

Who can help prepare an FDA 510(k) submission like VISART?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VISART

K961092 · Toshiba America Medical Systems, In.C · LNH · Jun 14, 1996 · Radiology

Device Facts

Record ID	K961092
Device Name	VISART
Applicant	Toshiba America Medical Systems, In.C
Product Code	LNH · Radiology
Decision Date	Jun 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart Nuclei excited: Hydrogen Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

Device Story

VISART™ is a magnetic resonance imaging (MRI) system upgrade for the MRT-150A platform. It utilizes a 1.5T static magnetic field to excite hydrogen nuclei, generating diagnostic images of the head, body, extremities, spine, neck, TMJ, and heart. Upgrades include increased gradient field strength (13.3T/sec), improved computer architecture, and a lighter magnet design. Operated by trained clinicians in a clinical setting, the system provides 2D/3D images, MR angiography, and MR fluoroscopy. Output is displayed for physician interpretation to assist in anatomical and pathological diagnosis. Patient safety is managed via acoustic noise protection due to elevated noise levels (up to 105.3 dB).

Clinical Evidence

Bench testing only. Performance demonstrated via sample phantom images and clinical images for all new sequences. Conformance with consensus standards verified for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing.

Technological Characteristics

1.5T static field MRI system. Features increased gradient field strength (13.3T/sec) and reduced RF power deposition (<0.4W/kg). Includes upgraded computer architecture and ergonomic interface. Employs hydrogen nuclei excitation. Acoustic noise levels reach 105.3 dB (H1) and 103.9 dB (F1).

Indications for Use

Indicated for whole-body diagnostic imaging, including head, abdomen, heart, pelvis, spine, blood vessels, and extremities, using hydrogen nuclei excitation for fluid visualization, 2D/3D imaging, MR angiography, and MR fluoroscopy.

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

MRT-150A (K903768A)
Flexart™ (K933018)
MRT-35A

Related Devices

K965068 — MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE · Toshiba America Medical Systems, In.C · Jul 15, 1997
K962138 — FLEXART V3.1 SOFTWARE · Toshiba America Mri, Inc. · Dec 23, 1996
K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR · Canon Medical Systems Corporation · Mar 27, 2026
K112003 — VANTAGE TITAN HSR · Toshibamedical Systems Corporation · Dec 2, 2011
K122613 — VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US · Toshiba America Medical Systems, In.C · Dec 13, 2012

Submission Summary (Full Text)

{0} K961092 JUN 14 1996 # 510(k) Summary ## SUMMARY OF SAFETY AND EFFECTIVENESS 1. Model Name: MRT-150A/H1 and MRT-150A/F1 Device Name: Magnetic Resonance Device Trade/Proprietary Name: VISART™ 2. Establishment Registration: #2020563 3. U.S. Agent Name and Address: TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92681-2068 Contact Person: Steven M. Kay (714) 730-5000 4. Manufacturing Site: Toshiba Corporation 1385 Shimoishigami Otawara-shi, Tochigi-Ken Japan 324 5. DATE OF SUBMISSION: March ? 1996 6. DEVICE DESCRIPTION The VISART™ consists of two model upgrades to the MRT-150A system which provide increased gradient field strength, more ergonomic computer architecture, improved scan parameter specifications and a lighter magnet than the MRT-150A. 7. SAFETY PARAMETERS | | MRT-150A | MRT-150/H1 | MRT-150/F1 | | --- | --- | --- | --- | | Maximum static field strength: | 1.5T | Same | Same | | Rate of change of magnetic field (τ = 1000ms): | 7.5T/sec, | 13.3T/sec. | 13.3T/sec. | | Max. Radio frequency power deposition: | <1.0W/kg | <0.4W/kg | <0.4W/kg | | Acoustic Noise levels: | 85 - 100 dB | 105.3 dB | 103.9 dB | | | (Typical) | (Maximum) | (Maximum) | Acoustic noise data was measured in accordance with NEMA guidelines. The user is cautioned to have the patient wear acoustic noise protection during scanning. {1} # 510(k) Summary (cont'd) ## SUMMARY OF SAFETY AND EFFECTIVENESS ### 8. IMAGING PERFORMANCE PARAMETERS | Specification volume: | Head: | MRT-150A | MRT-150/H1 | MRT-150/F1 | | --- | --- | --- | --- | --- | | | Body: | 10 cm dsv | 16cm dsv | 16cm dsv | | | | 20 cm dsv | 28cm dsv | 28cm dsv | Sample phantom images and clinical images were presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing. ### 9. INTENDED USE - Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart - Nuclei excited: Hydrogen - Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy ### 10. EQUIVALENCE INFORMATION Toshiba America Medical Systems, Inc. (TAMS) believes the VISART™ is substantially equivalent to the MRT-150A because it consists of hardware and software upgrades that improve the performance of the MRT-150A, without introducing new questions of safety or efficacy. The MRT-150A was cleared by K903768A. The improved computer system architecture and user interface were cleared with the Flexart™ via K933018. The increased gradient field strength is less than the IEC standard and that of other manufacturers systems currently on the market. New surface coils for this system received prior market clearance from the Agency. The new magnet offers siting and shipping advantages, but does not change the system's performance characteristics. Software upgrades provide for improved image quality, but do not change the intended uses of the device. MR Fluoroscopy is similar to the same function that was cleared for the MRT-35A. Good Manufacturing Practices requirements are unchanged from those already in effect for the MRT-150A.