510(k) K914821
K914821 is an FDA 510(k) premarket notification submitted by Consolidated Radiation Services, Inc. for the device "CRS RADIATION BEAM SCANNER". The FDA issued a decision of Substantially Equivalent on December 17, 1992. The device falls under product code IYI (Collimator, Orthovoltage, Therapeutic X-Ray), a Class II device regulated under 21 CFR 892.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1992
- Date Received
- October 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, Orthovoltage, Therapeutic X-Ray
- Device Class
- Class II
- Regulation Number
- 892.5900
- Review Panel
- RA
- Submission Type