The following data is part of a premarket notification filed by Mirada Medical Ltd with the FDA for Aline Ablation Intelligence.
| Device ID | K202297 |
| 510k Number | K202297 |
| Device Name: | Aline Ablation Intelligence |
| Classification | System, Image Processing, Radiological |
| Applicant | Mirada Medical Ltd New Barclay House, 234 Botley Road Oxford, GB Ox2 0hp |
| Contact | David Clafton |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-13 |
| Decision Date | 2020-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B334ALINE1P00 | K202297 | 000 |