The following data is part of a premarket notification filed by Maxq Al Ltd. with the FDA for Accipiolx.
| Device ID | K201310 |
| 510k Number | K201310 |
| Device Name: | Accipiolx |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | MaxQ Al Ltd. 96 Yigal Alon Street, 1st Floor Tel Aviv, IL 6789140 |
| Contact | Joshua Schulman |
| Correspondent | Joshua Schulman MaxQ Al Ltd. 96 Yigal Alon Street, 1st Floor Tel Aviv, IL 6789140 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-15 |
| Decision Date | 2020-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001219531 | K201310 | 000 |