510(k) K031991
K031991 is an FDA 510(k) premarket notification submitted by Image Analysis, Inc. for the device "DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS". The FDA issued a decision of Substantially Equivalent on Jul 30, 2003. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Image Analysis, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 2003
- Date Received
- Jun 27, 2003
- Clearance Type
- Special
- 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
- 510(k)