BriefCase-Triage
FDA 510(k) K242837 · Aidoc Medical , Ltd.
510(k) numberK242837
Submission
- Device name
- BriefCase-Triage
- Applicant
- Aidoc Medical , Ltd.
Tell-Aviv, IL - Received
- September 19, 2024
- Decision date
- October 18, 2024
- 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…
Other 510(k)s with product code QAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261085 | Rapid Vessel Occlusion (Rapid VO)QAS · Traditional | iSchemaview | 07/13/2026SE |
| K260729 | Vascular Assist Occlusion Triage (VAOT) (v1.0)QAS · Traditional | GuideAI Health | 06/18/2026SE |
| 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 |
| K252421 | Jlk-NcctQAS · Traditional | JLK, Inc. | 03/24/2026SE |
| 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 |
More from Mlhealth 360
| 510(k) | Device | Decision |
|---|---|---|
| K261317 | BriefCase-TriageQAS · Special | 05/14/2026SE |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…QAS · Traditional | 02/26/2026SE |
| K251195 | BriefCase-TriageQAS · Traditional | 01/27/2026SE |
| K252970 | BriefCase-Triage: CARE Multi-triage CT BodyQAS · Traditional | 01/07/2026SE |
| K253265 | BriefCase-TriageQAS · Special | 11/06/2025SE |
| K251406 | BriefCase-TriageQAS · Special | 05/30/2025SE |
| K250248 | BriefCase-TriageQAS · Special | 02/14/2025SE |
| K243548 | BriefCase-TriageQFM · Special | 12/11/2024SE |
| K242203 | BriefCase-QuantificationQIH · Traditional | 11/22/2024SE |
| K241727 | BriefCase-TriageQAS · Special | 07/12/2024SE |
Questions and answers
When was BriefCase-Triage cleared by the FDA?
BriefCase-Triage (K242837) received a 510(k) decision of Substantially Equivalent on October 18, 2024, 29 days after the submission was received.
What is the product code of K242837?
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.