← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K963953 # IMIG-MRI (K963953) _Imig-Mri Systems, LLC · LNH · Dec 18, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K963953 ## Device Facts - **Applicant:** Imig-Mri Systems, LLC - **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md) - **Decision Date:** Dec 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 (508) 649-8590; FAX (508) 649-8520 Regulatory Counsel: Jonathon S. Kahan, Attorney at Law Hogan & Hartson 555 Thirteenth Street N.W., Washington D.C. 20004-1109 (202) 637-5794; FAX (202) 637-5910 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 & Maintenance Guide) Substantial equivalence: This device has the same intended use and basic technological characteristics as the Siemens Magnetom P8. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K963953](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K963953) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com