The following data is part of a premarket notification filed by Cirdan Imaging Ltd with the FDA for Solas Or.
| Device ID | K213691 |
| 510k Number | K213691 |
| Device Name: | Solas OR |
| Classification | Cabinet, X-ray System |
| Applicant | Cirdan Imaging Ltd The Green, Tullynacross Rd, Lambeg Lisburn, GB Bt27 5sr |
| Contact | Paul Matthews |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-11-23 |
| Decision Date | 2021-12-22 |