510(k) K882492
K882492 is an FDA 510(k) premarket notification submitted by Applied X-Ray Technologies, Inc. for the device "A.X.T. SPOTFILM DEVICE". The FDA issued a decision of Substantially Equivalent on July 21, 1988. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Applied X-Ray Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1988
- Date Received
- June 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Spot-Film
- Device Class
- Class II
- Regulation Number
- 892.1670
- Review Panel
- RA
- Submission Type