The following data is part of a premarket notification filed by Elekta Oncology Systems, Inc. with the FDA for Elekta Oncology Systems Icom/quickmode Software Options.
| Device ID | K973540 |
| 510k Number | K973540 |
| Device Name: | ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA ONCOLOGY SYSTEMS, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 -0917 |
| Contact | Peter Altman |
| Correspondent | Peter Altman ELEKTA ONCOLOGY SYSTEMS, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 -0917 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1997-12-17 |
| Summary: | summary |