The following data is part of a premarket notification filed by Brainomix Limited with the FDA for Brainomix 360 E-cta.
| Device ID | K192692 |
| 510k Number | K192692 |
| Device Name: | Brainomix 360 E-CTA |
| Classification | System, Image Processing, Radiological |
| Applicant | Brainomix Limited Suites 11-14 Suffolk House, 263 Banbury Road Oxford, GB Ox2 7hn |
| Contact | Gwilym Owen |
| Correspondent | Gwilym Owen Brainomix Limited Suites 11-14 Suffolk House, 263 Banbury Road Oxford, GB Ox2 7hn |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B720BX360ECTA1110 | K192692 | 000 |