Cina Chest
FDA 510(k) K210237 · Avicenna.Ai
510(k) numberK210237
Submission
- Device name
- Cina Chest
- Applicant
- Avicenna.Ai
La Ciotat, FR - Received
- January 28, 2021
- Decision date
- May 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K261317 | BriefCase-TriageQAS · Special | Aidoc Medical , Ltd. | 05/14/2026SE |
| K253163 | Efai Ersuite CT Appendicitis Assessment System (APPEN-CT-100)QAS · Traditional | Ever Fortune.Ai, Co., Ltd. | 04/22/2026SE |
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| K253818 | Annalise EnterpriseQAS · Traditional | Harrison-AI Medical Pty, Ltd. | 03/03/2026SE |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…QAS · Traditional | Aidoc Medical , Ltd. | 02/26/2026SE |
| K251195 | BriefCase-TriageQAS · Traditional | Aidoc Medical , Ltd. | 01/27/2026SE |
| K252970 | BriefCase-Triage: CARE Multi-triage CT BodyQAS · Traditional | Aidoc Medical , Ltd. | 01/07/2026SE |
| K250694 | Scaida BrainCT-ICH (v1.0)QAS · Traditional | Mlhealth 360 | 11/25/2025SE |
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Questions and answers
When was Cina Chest cleared by the FDA?
Cina Chest (K210237) received a 510(k) decision of Substantially Equivalent on May 19, 2021, 111 days after the submission was received.
What is the product code of K210237?
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.