510(k) K865100
K865100 is an FDA 510(k) premarket notification submitted by Computerized Imaging Reference Systems, Inc. for the device "TISSUE-EQUIVALENT BREAST SIMULATOR". The FDA issued a decision of Substantially Equivalent on January 12, 1987. The device falls under product code IXF (Test-Pattern, Radiographic), a Class I device regulated under 21 CFR 892.1940. Computerized Imaging Reference Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1987
- Date Received
- December 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test-Pattern, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1940
- Review Panel
- RA
- Submission Type