BriefCase
Radiological Computer-assisted Triage And Notification Software
Aidoc Medical, Ltd.
The following data is part of a premarket notification filed by Aidoc Medical, Ltd. with the FDA for Briefcase.
Pre-market Notification Details
| Device ID | K190896 |
| 510k Number | K190896 |
| Device Name: | BriefCase |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Aidoc Medical, Ltd. 92 Yigal Alon St. Tel-aviv, IL 6789134 |
| Contact | Nimrod Epstein |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-05 |
| Decision Date | 2019-05-31 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018052211 | K190896 | 000 |
| 07290018052259 | K190896 | 000 |
| 07290018052297 | K190896 | 000 |
| 07290018052273 | K190896 | 000 |
Trademark Results [BriefCase]
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