510(k) K914821
- Device
- CRS RADIATION BEAM SCANNER
- Applicant
- CONSOLIDATED RADIATION SERVICES, INC.
- 510(k) number
- K914821
- Product code
- IYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-17
- Date received
- 1991-10-25
- Regulation
- 892.5900
- Classification name
- Collimator, Orthovoltage, Therapeutic X-ray
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BO ANDERSSON
- Address
- 140 Sopwith Dr. Vero Beach FL US 32968 32968
Source Documents#
Other 510(k) Records For Product Code IYI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900932 | 37-702 AND 37-703 PC RAINBOW | Victoreen, Inc. | 1990-12-05 |
Legacy Summary#
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FDA Review#
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