Aidoc Medical , Ltd.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Aidoc Medical , Ltd.” (first 2018, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 132 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Aidoc Medical , Ltd. 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Aidoc Medical , Ltd.?
FDA lists 35 510(k) clearances under the applicant name “Aidoc Medical , Ltd.” (first 2018, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aidoc Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aidoc Medical , Ltd. is 90 days. Since 2017: 90 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aidoc Medical , Ltd.?
The most frequent FDA product codes under this applicant name 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).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.