(77 days)
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No
The summary does not mention AI, ML, or any related terms, and the performance metrics are standard for an MRI device without AI/ML features.
No
The 'Intended Use / Indications for Use' section explicitly states 'Diagnostic uses: Imaging', and the 'Device Description' identifies it as a 'Magnetic Resonance Diagnostic Device', indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic uses: Imaging," and the "Device Description" identifies it as a "Magnetic Resonance Diagnostic Device."
No
The device description explicitly states "Magnetic Resonance Diagnostic Device," which is a hardware-based imaging system. The performance studies also detail hardware-specific metrics like S/N, uniformity, and geometric distortion, further indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states "Magnetic Resonance Diagnostic Device." Magnetic Resonance Imaging (MRI) is an in vivo imaging technique. It creates images of the inside of the body without taking samples.
- Intended Use: The intended use is "Imaging" of various anatomical sites (head, limbs, spine, torso). This is consistent with an imaging device, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, based on the provided information, this device is a medical imaging device, specifically an MRI machine, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Anatomy: head, limbs, spine, torso; Nuclei: H-1; Diagnostic uses: Imaging
Product codes
90LNH
Device Description
Magnetic Resonance Diagnostic Device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, limbs, spine, torso
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance test data summary:
(Receive coil:) (head) (body)
Specification volume: 15 cm dsv 30 cm dsv
S/N: > 32 > 31
Uniformity: 32 > 31
Uniformity:
§ 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.
0
DEC 1 8 1996
Kal 3953
IMIG-MRI 510(k) Summary
| Submitter: | IMIG-MRI Systems 1.1.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-MRITM |
| 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: |