IMAGENET 5 PC SOFTWARE SYSTEM— 510(k) K132438
Substantially EquivalentTopcon Medical Systems, Inc.
FDA 510(k) clearance K132438 for IMAGENET 5 PC SOFTWARE SYSTEM, Substantially Equivalent on 2013-10-17. Applicant: Topcon Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Topcon Medical Systems, Inc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Reading, MA, US
Recent devices under product code NFJ
view allMore clearances from Topcon Medical Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.