510(k) K874451
K874451 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "OMNIPLANE 200 FILM CHANGER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 11, 1988. The device falls under product code IZP (Programmer, Changer, Film/Cassette, Radiographic), a Class II device regulated under 21 CFR 892.1870. Medrad, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 1988
- Date Received
- October 28, 1987
- 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