The following data is part of a premarket notification filed by Eleckta Limited with the FDA for Precise Treatment System; Synergy Platform; Synergy; Infinity; Versahd.
| Device ID | K182138 |
| 510k Number | K182138 |
| Device Name: | Precise Treatment System; Synergy Platform; Synergy; Infinity; VersaHD |
| Classification | Accelerator, Linear, Medical |
| Applicant | Eleckta Limited Linac House, Fleming Way Crawley, GB Rh10 9rr |
| Contact | Andrew Hedges |
| Correspondent | Andrew Hedges Eleckta Limited Linac House, Fleming Way Crawley, 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 | 2018-08-07 |
| Decision Date | 2018-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060191071345 | K182138 | 000 |