510(k) K925650
K925650 is an FDA 510(k) premarket notification submitted by Nuclear Data Systems for the device "IMAGEVIEW 5000". The FDA issued a decision of Substantially Equivalent on September 14, 1993. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Nuclear Data Systems has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1993
- Date Received
- November 9, 1992
- 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