The following data is part of a premarket notification filed by Consolidated Radiation Services, Inc. with the FDA for Crs Radiation Beam Scanner.
Device ID | K914821 |
510k Number | K914821 |
Device Name: | CRS RADIATION BEAM SCANNER |
Classification | Collimator, Orthovoltage, Therapeutic X-ray |
Applicant | CONSOLIDATED RADIATION SERVICES, INC. 140 SOPWITH DR. Vero Beach, FL 32968 |
Contact | Bo Andersson |
Correspondent | Bo Andersson CONSOLIDATED RADIATION SERVICES, INC. 140 SOPWITH DR. Vero Beach, FL 32968 |
Product Code | IYI |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-25 |
Decision Date | 1992-12-17 |