IMIG-MRI

K963953 · Imig-Mri Systems, LLC · LNH · Dec 18, 1996 · Radiology

Device Facts

• Record ID: K963953
• Device Name: IMIG-MRI
• Applicant: Imig-Mri Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

Anatomy: head, limbs, spine, torso; Nuclei: H-1; Diagnostic uses: Imaging

Device Story

Magnetic resonance diagnostic device; 0.15 Tesla static magnetic field; generates diagnostic images of head, limbs, spine, torso. Operated by trained personnel in clinical settings. System utilizes RF power and magnetic field gradients to acquire signals; processes signals to produce anatomical images. Healthcare providers use images for diagnostic assessment. Benefits include non-invasive visualization of internal anatomy.

Clinical Evidence

Bench testing only. Performance data provided for head and body receive coils including signal-to-noise ratio (S/N > 32 head, > 31 body), uniformity (< 15% head, < 40% body), geometric distortion (< 2.5% head, < 3.5% body), slice thickness/position accuracy, and spatial resolution.

Technological Characteristics

0.15 Tesla static magnetic field; 18.4 Tesla/sec max rate of magnetic field change; 0.05 W/kg max RF power deposition; 114 dB peak acoustic noise. Includes head and body receive coils. Performance specifications: 15 cm dsv (head) and 30 cm dsv (body) volumes.

Indications for Use

Indicated for diagnostic imaging of the head, limbs, spine, and torso using H-1 nuclei.

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

• Siemens Magnetom P8

Submission Summary (Full Text)

{0}

DEC 18 1996

K963953

IMIG-MRI 510(k) Summary

Submitter: IMIG-MRI Systems I.I.c., 300 Vesper Executive Park, Tyngsborough MA 01879

Company contact: Greg Hurst, Ph.D., Manager of Imaging Science and Applications
[phone]; FAX [phone]

Regulatory Counsel: Jonathon S. Kahan, Attorney at Law
Hogan &amp; Hartson
555 Thirteenth Street N.W., Washington D.C. 20004-1109
[phone]; FAX [phone]

Date of Summary Preparation: 18 September 1996

Device Name: Magnetic Resonance Diagnostic Device.

Classification Number: 90LNH

Device Class: Class II, under 21 CFR 892.1000

Device Trade Name: IMIG-MRI™

Intended Uses: Anatomy: head, limbs, spine, torso; Nuclei: H-1; Diagnostic uses: Imaging

Predicate Device: Siemens Magnetom P8

Safety parameter data summary:
Maximum static magnetic field: 0.15 Tesla
Maximum rate of magnetic field change: 18.4 Tesla/sec
Maximum RF power deposition: .05 W/kg
Acoustic noise levels: 114 dB peak; 95 dB A-weighted RMS

Performance test data summary:
| (Receive coil:) | (head) | (body) |
| --- | --- | --- |
| Specification volume: | 15 cm dsv | 30 cm dsv |
| S/N: | > 32 | > 31 |
| Uniformity: | < 15 % | < 40 % |
| Geometric distortion: | < 2.5 % | < 3.5 % |

Slice thickness: within 10% of nominally designated value
Slice position (gap): within 10% of nominally designated value
Spatial resolution: nominally equivalent to pixel size

General safety and effectiveness concerns: Safe and effective use of the machine is assured by associated labeling. This labeling includes: advertising brochures, Site Planning Guide, and Instructions for Use (comprised of Clinical Users Guide, User Safety Guide, User Training Guide, User Applications Guide, and User QA &amp; Maintenance Guide)

Substantial equivalence: This device has the same intended use and basic technological characteristics as the Siemens Magnetom P8.