510(k) K852528
K852528 is an FDA 510(k) premarket notification submitted by Computerized Imaging Reference Systems, Inc. for the device "BONE DENSITY CT PHANTOM". The FDA issued a decision of Substantially Equivalent on September 26, 1985. The device falls under product code IXG (Phantom, Anthropomorphic, Radiographic), a Class I device regulated under 21 CFR 892.1950. Computerized Imaging Reference Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1985
- Date Received
- June 14, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phantom, Anthropomorphic, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1950
- Review Panel
- RA
- Submission Type