The following data is part of a premarket notification filed by Sun Nuclear Corporation with the FDA for Arccheck-mr.
| Device ID | K160057 |
| 510k Number | K160057 |
| Device Name: | ArcCHECK-MR |
| Classification | Accelerator, Linear, Medical |
| Applicant | Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 |
| Contact | James Luker |
| Correspondent | James Luker 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 | 2016-01-12 |
| Decision Date | 2016-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01612200000MR0 | K160057 | 000 |
| 05060608880355 | K160057 | 000 |