Data / Medical devices / Israel / Aisap Ltd
Aisap Ltd: FDA-registered device maker in Ramat Gan Central, Israel, 1 510(k) clearance
Aisap Ltd is registered with the FDA (registration 3040335643) in Ramat Gan Central, Israel. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 1, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3040335643
- Address
- Sheba Road 2, Ramat Gan Central, Israel, 5266202
- Owner or operator
- AISAP LTD (10093956)
- Roles
- Manufacturer
- First device listed
- August 21, 2025
- Registered through
- 2027
- Brand names listed
- AISAP CARDIO V1, AISAP Cardio, AISAP Cardio V1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 1, 2024 | K234141 | AISAP Cardio V1.0 | POK | Substantially Equivalent | Aisap | accessdata.fda.gov |
Compare with other makers
- All makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- All makers of Automated Radiological Image Processing Software
Updated August 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.