FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
TBS INSIGHT
K Number: K121716
·
Decision Oct 5, 2012
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
3
Review Days
116
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TBS INSIGHT
- K Number
- K121716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medimaps Group SA
- Date Received
- June 11, 2012
- Decision Date
- October 5, 2012
- Product Code
- KGI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGI), ordered by most recent decision date.
Lunar Astra
FDA 510(k)
FDA Class 2
·Radiology
3D-SHAPER
FDA 510(k)
FDA Class 2
·Radiology
BunkerHill BMD
FDA 510(k)
FDA Class 2
·Radiology
TBS iNsight (V4)
FDA 510(k)
FDA Class 2
·Radiology
VirtuOst
FDA 510(k)
FDA Class 2
·Radiology
3D-SHAPER
FDA 510(k)
FDA Class 2
·Radiology