510(k) K243548
- Device
- BriefCase-Triage
- Applicant
- Aidoc Medical , Ltd.
- 510(k) number
- K243548
- Product code
- QFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-11
- Date received
- 2024-11-15
- Regulation
- 892.2080
- Classification name
- Radiological Computer-Assisted Prioritization Software For Lesions
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amalia Schreier
- Address
- 3 Aminadav St. Tell-Aviv IL 6706703 6706703
FDA Registration Numbers#
- 3014678441
- 3007734888
- 3011205675
- 3021032044
- 3024844299
- 3034205378
- 3027453703
- 3021230777
- 3029915548
- 3023702863
- 2126677
- 3026753394
- 3030491946
- 3017604664
- 3012453401
- 3014938447
- 3018733944
- 3005156333
- 3014665798
- 9616047
- 3017173128
- 3017840913
Source Documents#
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| K230899 | qXR-PTX-PE | Qure.Ai Technologies | 2023-08-22 |
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| K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 |
| K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 |
| K223443 | Viz AAA | Viz. Ai, Inc. | 2023-03-17 |