510(k) K854251
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1985
- Date Received
- October 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Programmer, Changer, Film/Cassette, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1870
- Review Panel
- RA
- Submission Type