The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for Mapcheck2, Arccheck.
| Device ID | K131466 |
| 510k Number | K131466 |
| Device Name: | MAPCHECK2, ARCCHECK |
| Classification | Accelerator, Linear, Medical |
| Applicant | SUN NUCLEAR CORPORATION 3275 Suntree Blvd Melbourne, FL 32940 |
| Contact | Jeff Kapatoes |
| Correspondent | Jeff Kapatoes SUN NUCLEAR CORPORATION 3275 Suntree Blvd Melbourne, FL 32940 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-21 |
| Decision Date | 2013-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01612200000Z0 | K131466 | 000 |
| 05060608880621 | K131466 | 000 |
| 05060608880638 | K131466 | 000 |
| 05060608880645 | K131466 | 000 |
| 05060608880003 | K131466 | 000 |
| B0161122AZ0 | K131466 | 000 |
| B01611770000Z0 | K131466 | 000 |
| B0161177000EZ0 | K131466 | 000 |
| B0161177000SZ0 | K131466 | 000 |
| B0161177000VZ0 | K131466 | 000 |
| B01611780000Z0 | K131466 | 000 |
| B01611790000Z0 | K131466 | 000 |
| 05060608880188 | K131466 | 000 |