BriefCase
FDA 510(k) clearance K221330 · decided 2022-11-18
Clearance details
- K-number
- K221330
- Device name
- BriefCase
- Applicant
- Aidoc Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-06
- Decision date
- 2022-11-18
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- QAS
- Device class
- 2
- Regulation number
- 892.2080
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tell-Aviv, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Aidoc Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Rapid Vessel Occlusion (Rapid VO) (K261085) | iSchemaview | 2026-07-13 |
| Vascular Assist Occlusion Triage (VAOT) (v1.0) (K260729) | GuideAI Health | 2026-06-18 |
| BriefCase-Triage (K261317) | Aidoc Medical , Ltd. | 2026-05-14 |
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) (K253163) | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 |
| JLK-NCCT (K252421) | JLK, Inc. | 2026-03-24 |
| Annalise Enterprise (K253818) | Harrison-AI Medical Pty, Ltd. | 2026-03-03 |
| BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device (K253578) | Aidoc Medical , Ltd. | 2026-02-26 |
| BriefCase-Triage (K251195) | Aidoc Medical , Ltd. | 2026-01-27 |
| BriefCase-Triage: CARE Multi-triage CT Body (K252970) | Aidoc Medical , Ltd. | 2026-01-07 |
| Scaida BrainCT-ICH (v1.0) (K250694) | Mlhealth 360 | 2025-11-25 |
| a2z-Unified-Triage (K252366) | A2z Radiology Ai, Inc. | 2025-11-24 |
| BriefCase-Triage (K253265) | Aidoc Medical , Ltd. | 2025-11-06 |
Recalls involving this device
No recalls on record reference this clearance.