The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Mlci2.
| Device ID | K082122 |
| 510k Number | K082122 |
| Device Name: | MLCI2 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex, GB Rh10 9rr |
| Contact | Patrick T Hull |
| Correspondent | Patrick T Hull ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex, GB Rh10 9rr |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-28 |
| Decision Date | 2008-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060191071024 | K082122 | 000 |