The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Collimaster-90.
| Device ID | K911127 |
| 510k Number | K911127 |
| Device Name: | COLLIMASTER-90 |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | VARIAN ASSOC., INC. 301 INDUSTRIAL WAY San Carlos, CA 94070 |
| Contact | Linda Larsen |
| Correspondent | Linda Larsen VARIAN ASSOC., INC. 301 INDUSTRIAL WAY San Carlos, CA 94070 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-14 |
| Decision Date | 1991-09-19 |