510(k) K900932
- Device
- 37-702 AND 37-703 PC RAINBOW
- Applicant
- VICTOREEN, INC.
- 510(k) number
- K900932
- Product code
- IYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-05
- Date received
- 1990-02-28
- Regulation
- 892.5900
- Classification name
- Collimator, Orthovoltage, Therapeutic X-ray
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GLASSER
- Address
- 100 Voice Rd. Carle Place NY US 11514 11514
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914821 | CRS RADIATION BEAM SCANNER | Consolidated Radiation Services, Inc. | 1992-12-17 |
Legacy Summary#
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FDA Review#
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