Cina
FDA 510(k) K221716 · Avicenna.Ai
510(k) numberK221716
Submission
- Device name
- Cina
- Applicant
- Avicenna.Ai
La Ciotat, FR - Received
- June 13, 2022
- Decision date
- November 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAS – Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on…
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More from Mlhealth 360
| 510(k) | Device | Decision |
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| K240942 | CINA-CSpineQAS · Traditional | 09/12/2024SE |
| K240612 | Cina-VcfQFM · Traditional | 05/31/2024SE |
| K233342 | Cina-AspectsPOK · Traditional | 03/15/2024SE |
| K233968 | CINA-iPEQAS · Traditional | 03/13/2024SE |
| K210237 | Cina ChestQAS · Traditional | 05/19/2021SE |
| K200855 | CinaQAS · Traditional | 06/24/2020SE |
Questions and answers
When was Cina cleared by the FDA?
Cina (K221716) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 162 days after the submission was received.
What is the product code of K221716?
The FDA product code is QAS – Radiological Computer-Assisted Triage And Notification Software, a Class II (moderate risk) device regulated under 21 CFR 892.2080.