The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Beam Modulator, Model 4513 332 8000.
| Device ID | K042794 |
| 510k Number | K042794 |
| Device Name: | BEAM MODULATOR, MODEL 4513 332 8000 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA LTD. 4775 PEACHTREE INDUSTRIAL BLVD BLDG. 300, SUITE 300 Norcross, GA 30092 |
| Contact | Peter Stegagno |
| Correspondent | Peter Stegagno ELEKTA LTD. 4775 PEACHTREE INDUSTRIAL BLVD BLDG. 300, SUITE 300 Norcross, GA 30092 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-07 |
| Decision Date | 2005-01-31 |
| Summary: | summary |