Aidoc Medical , Ltd.: FDA clearances and approvals
Aidoc Medical , Ltd. has 35 FDA 510(k) clearances (first 2018, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time: 90 days. Since 2017 its median was 90 days, against 132 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 142 |
| 2019 | 3 | 90 |
| 2020 | 3 | 131 |
| 2021 | 1 | 196 |
| 2022 | 10 | 86 |
| 2023 | 5 | 123 |
| 2024 | 5 | 28 |
| 2025 | 3 | 24 |
| 2026 | 4 | 106 |
Review time against the same product codes
Since 2017, Aidoc Medical , Ltd.'s cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | 25 | 25 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 5 | 5 |
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
Review panels
- Radiology (35)
Most recent Aidoc Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261317 | BriefCase-Triage | QAS | 2026-05-14 | 23 |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device | QAS | 2026-02-26 | 101 |
| K251195 | BriefCase-Triage | QAS | 2026-01-27 | 285 |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body | QAS | 2026-01-07 | 112 |
| K253265 | BriefCase-Triage | QAS | 2025-11-06 | 38 |
| K251406 | BriefCase-Triage | QAS | 2025-05-30 | 24 |
| K250248 | BriefCase-Triage | QAS | 2025-02-14 | 18 |
| K243548 | BriefCase-Triage | QFM | 2024-12-11 | 26 |
| K242203 | BriefCase-Quantification | QIH | 2024-11-22 | 119 |
| K242837 | BriefCase-Triage | QAS | 2024-10-18 | 29 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aidoc Medical , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Aidoc Medical , Ltd. have?
Aidoc Medical , Ltd. has 35 FDA 510(k) clearances (first 2018, latest 2026), across 4 product codes in 1 review panel.
How long does FDA take to clear Aidoc Medical , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Aidoc Medical , Ltd.'s cleared 510(k)s is 90 days. Since 2017: 90 days, versus 132 days for all cleared 510(k)s in the same product codes.
What devices does Aidoc Medical , Ltd. make?
Its most frequent FDA product codes are QAS (Radiological Computer-Assisted Triage And Notification Software, 25); QFM (Radiological Computer-Assisted Prioritization Software For Lesions, 5); QIH (Automated Radiological Image Processing Software, 4).
Has Aidoc Medical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aidoc Medical , Ltd. Related entities may recall under other names.
Next steps
- See all 35 Aidoc Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QAS, Aidoc Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.