IMAGENET 5 PC SOFTWARE SYSTEM
FDA 510(k) clearance K132438 · decided 2013-10-17
Clearance details
- K-number
- K132438
- Device name
- IMAGENET 5 PC SOFTWARE SYSTEM
- Applicant
- Topcon Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-05
- Decision date
- 2013-10-17
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- North Reading, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.