510(k) K200921
- Device
- QER
- Applicant
- Qure.ai Technologies
- 510(k) number
- K200921
- Product code
- QAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-06-17
- Date received
- 2020-04-06
- Regulation
- 892.2080
- Classification name
- Radiological Computer-assisted Triage And Notification Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Pooja Rao
- Address
- Level 7, Commerz Ii, International Business Park, Oberoi Garden City, Mumbai IN 400063 400063
FDA Registration Numbers#
- 3035495311
- 3017936680
- 3014678441
- 3011205675
- 3021032044
- 3023702863
- 3004977335
- 3021915828
- 3015763655
- 3017604664
- 3012453401
- 3038177848
- 3014938447
- 3014665798
- 3007301305
- 3034656245
- 3017210169
- 3016727312
- 3017840913
Source Documents#
Other 510(k) Records For Product Code QAS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261317 | BriefCase-Triage | Aidoc Medical , Ltd. | 2026-05-14 |
| K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 |
| K252421 | JLK-NCCT | JLK, Inc. | 2026-03-24 |
| K253818 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | 2026-03-03 |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | Aidoc Medical , Ltd. | 2026-02-26 |
| K251195 | BriefCase-Triage | Aidoc Medical , Ltd. | 2026-01-27 |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body | Aidoc Medical , Ltd. | 2026-01-07 |
| K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | 2025-11-25 |
| K252366 | a2z-Unified-Triage | A2z Radiology Ai, Inc. | 2025-11-24 |
| K253265 | BriefCase-Triage | Aidoc Medical , Ltd. | 2025-11-06 |
| K251610 | qER-CTA (v1.0) | Qure.Ai Technologies | 2025-09-08 |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | 2025-09-04 |
| K251983 | Brainomix 360 Triage Stroke | Brainomix Limited | 2025-08-26 |
| K251590 | Methinks CTA Stroke | Methinks Software, S.L | 2025-08-20 |
| K251151 | Rapid CTA 360 | Ischemaview | 2025-07-16 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases