LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM— 510(k) K950431
Substantially EquivalentOpen Mri, Inc.
FDA 510(k) clearance K950431 for LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM, Substantially Equivalent on 1995-05-04. Applicant: Open Mri, Inc.. Device class: 1.
Clearance details
- Applicant
- Open Mri, Inc.
- Product code
- Code LMD
- Device class
- Class 1
- Regulation
- 21 CFR 892.2020
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hayward, CA, US
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