510(k) K884650
K884650 is an FDA 510(k) premarket notification submitted by Orion Corp. for the device "RESUBMITTED SCANORA". The FDA issued a decision of Substantially Equivalent on Mar 16, 1989. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Orion Corp. has 20 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 1989
- Date Received
- Nov 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomographic
- Device Class
- Class II
- Regulation Number
- 892.1740
- Review Panel
- RA
- Submission Type
- 510(k)