The following data is part of a premarket notification filed by Elekta Limited with the FDA for Integrity(tm).
| Device ID | K112613 |
| 510k Number | K112613 |
| Device Name: | INTEGRITY(TM) |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Limited LINAC HOUSE Crawley, West Sussex, GB Rh10 9rr |
| Contact | Andrew Hedges |
| Correspondent | Andrew Hedges Elekta Limited LINAC HOUSE Crawley, West Sussex, GB Rh10 9rr |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060191071062 | K112613 | 000 |