510(k) K852509
K852509 is an FDA 510(k) premarket notification submitted by Image Analysis, Inc. for the device "QCT-BONE MINERAL PHANTOM". The FDA issued a decision of Substantially Equivalent on Oct 18, 1985. 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
- Oct 18, 1985
- Date Received
- Jun 12, 1985
- 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
- 510(k)