The following data is part of a premarket notification filed by Mirada Medical Ltd. with the FDA for Workflow Box.
| Device ID | K181572 |
| 510k Number | K181572 |
| Device Name: | Workflow Box |
| Classification | System, Image Processing, Radiological |
| Applicant | Mirada Medical Ltd. Oxford Centre For Innovation, New Road Oxford, GB Ox1 Iby |
| 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 | 2018-06-14 |
| Decision Date | 2018-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B334WORKFLOWBOX2P00 | K181572 | 000 |
| B334WORKFLOWBOX2P20 | K181572 | 000 |
| B334WORKFLOWBOX2P40 | K181572 | 000 |
| B334WORKFLOWBOX2P60 | K181572 | 000 |