The following data is part of a premarket notification filed by Mirada Medical Ltd. with the FDA for Mirada Rtx.
| Device ID | K130393 |
| 510k Number | K130393 |
| Device Name: | MIRADA RTX |
| Classification | System, Image Processing, Radiological |
| Applicant | MIRADA MEDICAL LTD. OXFORD CENTRE FOR INNOVATION NEW ROAD Oxford, Oxfordshire, GB Ox1 1by |
| Contact | Gwilym Owen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-02-15 |
| Decision Date | 2013-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B334RTX1P80 | K130393 | 000 |
| B334RTX1P60 | K130393 | 000 |
| B334RTX1P100 | K130393 | 000 |