NT SERIES DIGITAL IMAGE MANAGER
FDA 510(k) clearance K955232 · decided 1995-12-11
Clearance details
- K-number
- K955232
- Device name
- NT SERIES DIGITAL IMAGE MANAGER
- Applicant
- Camtronics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-14
- Decision date
- 1995-12-11
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hartland, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.