IES, IMAGE ENHANCEMENT SYSTEM
FDA 510(k) clearance K922470 · decided 1992-11-27
Clearance details
- K-number
- K922470
- Device name
- IES, IMAGE ENHANCEMENT SYSTEM
- Applicant
- Open Mri, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-26
- Decision date
- 1992-11-27
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- West Cadwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.