The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for High-definition 120 Multileaf Collimator (hd120 Mlc).
| Device ID | K071992 |
| 510k Number | K071992 |
| Device Name: | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 -1129 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 -1129 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-20 |
| Decision Date | 2007-08-15 |
| Summary: | summary |