510(k) K024188
K024188 is an FDA 510(k) premarket notification submitted by Sony Medical Systems for the device "UP-DF500 FILMSTATION DIGITAL FILM IMAGER". The FDA issued a decision of Substantially Equivalent on February 4, 2003. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Sony Medical Systems has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2003
- Date Received
- December 19, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Multi Format, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2040
- Review Panel
- RA
- Submission Type