FDA Registration
Active
🇮🇱 Israel
AIDOC MEDICAL LTD.
Reg #: 3014938447
·
FEI: 3014938447
·
Expires 2026
Products
5
Proprietary Names
15
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- AIDOC MEDICAL LTD.
- Registration Number
- 3014938447
- FEI Number
- 3014938447
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 34, Ha-Masger
- City
- Tel Aviv-Yafo
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K241727
Owner / Operator
- Firm Name
- Aidoc Medical Ltd.
- Operator Number
- 10058842
- Address
- 34 hamasger st
- City
- Tel-Aviv
- State
- Tel Aviv
- Postal Code
- 6721119
- Country
- IL
- Correspondent
- Amalia Schreier
US Agent
- Business Name
- Aidoc Inc.
- Contact Name
- Arvind Kadaba
- Address
- 1674 Broadway Fl 4
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 860 5931983
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer-Assisted Triage And Notification Software | QAS | Class 2 | Radiology | No | 2024-07-22 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-11-26 |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | Class 2 | Radiology | No | 2023-02-22 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2021-11-02 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2023-12-18 |
Proprietary Names
BriefCase-Triage for PE
BriefCase
BriefCase-Triage for AD
BriefCase-Quantification of Aortic Measurement (M-Aorta)
aiOS
BriefCase-Quantification MLS
BriefCase-Triage for iPE
BriefCase-Triage: CARE Multi-triage CT Body
BriefCase-Quantification CAC
BriefCase-Triage Central PE
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture
BriefCase-Triage
BriefCase-Triage for CSF
BriefCase-Quantification of M-AbdAo
BriefCase-Triage for BA
Establishment Types
Manufacture Medical Device