Simplicit90Y
System, Image Processing, Radiological
Mirada Medical Ltd.
The following data is part of a premarket notification filed by Mirada Medical Ltd. with the FDA for Simplicit90y.
Pre-market Notification Details
| Device ID | K182016 |
| 510k Number | K182016 |
| Device Name: | Simplicit90Y |
| Classification | System, Image Processing, Radiological |
| Applicant | Mirada Medical Ltd. Oxford Center For Innovation, New Road Oxford, GB Ox1 1by |
| Contact | Sarah Bond |
| Correspondent | Sarah Bond Mirada Medical Ltd. Oxford Center For Innovation, New Road Oxford, GB Ox1 1by |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B334SY2P00 | K182016 | 000 |
| B334SY2P20 | K182016 | 000 |
| B334SY2P40 | K182016 | 000 |
| B334SY2P60 | K182016 | 000 |
| B334SY2P10 | K182016 | 000 |
| B334SY2P120 | K182016 | 000 |
| B334SY2P160 | K182016 | 000 |
Trademark Results [Simplicit90Y]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLICIT90Y 88232299 not registered Live/Pending |
Biocompatibles UK Limited 2018-12-17 |
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