510(k) K033637
K033637 is an FDA 510(k) premarket notification submitted by Array Corp. for the device "MEDICAL IMAGE DIGITIZER, MODEL 2908". The FDA issued a decision of Substantially Equivalent on December 17, 2003. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Array Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2003
- Date Received
- November 19, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digitizer, Image, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2030
- Review Panel
- RA
- Submission Type