Quantib B.V.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Quantib B.V.” (first 2016, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 73 days. Since 2017 the median was 72 days, against 131 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 |
|---|---|---|
| 2016 | 1 | 210 |
| 2017 | 1 | 70 |
| 2018 | 2 | 86 |
| 2019 | 0 | — |
| 2020 | 2 | 57 |
| 2021 | 0 | — |
| 2022 | 2 | 37 |
| 2023 | 1 | 27 |
| 2024 | 0 | — |
| 2025 | 1 | 129 |
| 2026 | 1 | 159 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Quantib B.V. took a median 72 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 9 | 9 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (11)
Most recent Quantib B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253682 | DeepHealth ProstateAI | QDQ | 2026-04-29 | 159 |
| K251527 | Brain WMH | QIH | 2025-09-25 | 129 |
| K230772 | Quantib Prostate | LLZ | 2023-04-17 | 27 |
| K221106 | Quantib Prostate | LLZ | 2022-05-13 | 28 |
| K213737 | Quantib ND | LLZ | 2022-01-14 | 46 |
| K202501 | Quantib Prostate | LLZ | 2020-10-11 | 41 |
| K200899 | Quantib AI Node | LLZ | 2020-06-15 | 73 |
| K182564 | Quantib ND | LLZ | 2018-12-27 | 100 |
| K173939 | Quantib Brain | LLZ | 2018-03-09 | 73 |
| K163013 | Quantib Brain 1.2 | LLZ | 2017-01-06 | 70 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Quantib B.V..
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 Quantib B.V.?
FDA lists 11 510(k) clearances under the applicant name “Quantib B.V.” (first 2016, latest 2026), across 3 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 Quantib B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantib B.V. is 73 days. Since 2017: 72 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Quantib B.V.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 9); QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, 1); QIH (Automated Radiological Image Processing Software, 1).
Next steps
- See all 11 Quantib B.V. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Quantib B.V.'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.