Qure.Ai Technologies: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Qure.Ai Technologies” (first 2020, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 144 days. Since 2017 the median was 144 days, against 137 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 |
|---|---|---|
| 2020 | 1 | 72 |
| 2021 | 2 | 108 |
| 2022 | 0 | — |
| 2023 | 3 | 154 |
| 2024 | 1 | 151 |
| 2025 | 1 | 104 |
| 2026 | 1 | 206 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Qure.Ai Technologies took a median 144 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| MYN | Analyzer, Medical Image | 2 | 2 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 2 | 2 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 1 | 1 |
Review panels
- Radiology (9)
Most recent Qure.Ai Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251934 | qXR-Detect | MYN | 2026-01-16 | 206 |
| K251610 | qER-CTA (v1.0) | QAS | 2025-09-08 | 104 |
| K240740 | qCT LN Quant | QIH | 2024-08-16 | 151 |
| K231805 | qXR-LN | MYN | 2023-12-22 | 185 |
| K231149 | qXR-CTR | QIH | 2023-09-22 | 154 |
| K230899 | qXR-PTX-PE | QFM | 2023-08-22 | 144 |
| K212690 | qXR-BT | QIH | 2021-12-21 | 118 |
| K211222 | qER-Quant | QIH | 2021-07-30 | 98 |
| K200921 | qER | QAS | 2020-06-17 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Qure.Ai Technologies.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Qure.Ai Technologies Pvt. , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Qure.Ai Technologies?
FDA lists 9 510(k) clearances under the applicant name “Qure.Ai Technologies” (first 2020, 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 Qure.Ai Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Qure.Ai Technologies is 144 days. Since 2017: 144 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Qure.Ai Technologies?
The most frequent FDA product codes under this applicant name are QIH (Automated Radiological Image Processing Software, 4); MYN (Analyzer, Medical Image, 2); QAS (Radiological Computer-Assisted Triage And Notification Software, 2).
Next steps
- See all 9 Qure.Ai Technologies clearances with predicates and recalls
- Run predicate analysis for product code QIH, Qure.Ai Technologies'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.