The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Rpm Respiratory Gating System.
| Device ID | K102024 |
| 510k Number | K102024 |
| Device Name: | RPM RESPIRATORY GATING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS 911 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS 911 HANSEN WAY Palo Alto, CA 94304 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2010-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899475002264 | K102024 | 000 |
| 10858086006396 | K102024 | 000 |
| 10858086006389 | K102024 | 000 |
| 10858086006624 | K102024 | 000 |
| 10858086006617 | K102024 | 000 |
| 00899475002479 | K102024 | 000 |