The following data is part of a premarket notification filed by Mirada Medical Ltd. with the FDA for Mirada Xd.
| Device ID | K101228 |
| 510k Number | K101228 |
| Device Name: | MIRADA XD |
| Classification | System, Image Processing, Radiological |
| Applicant | MIRADA MEDICAL LTD. MILL STREET INNOVATION HOUSE Oxford, Oxfordshire, GB Ox2 0jx |
| 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 | 2010-05-03 |
| Decision Date | 2010-06-23 |
| Summary: | summary |