510(k) K082402
K082402 is an FDA 510(k) premarket notification submitted by Imaging Therapeutics, Inc. for the device "OSDX HIP BMD SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 2008. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Imaging Therapeutics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2008
- Date Received
- August 20, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer, Bone
- Device Class
- Class II
- Regulation Number
- 892.1170
- Review Panel
- RA
- Submission Type