Quantitative Insights, Inc.: FDA clearances and approvals
Quantitative Insights, Inc. has 1 FDA 510(k) clearance (first 2017, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 114 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 114 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Quantitative Insights, Inc.'s cleared 510(k)s took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 1 | 0 |
Review panels
- Radiology (2)
Most recent Quantitative Insights, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170195 | QuantX | LLZ | 2017-05-17 | 114 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170022 | De Novo | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2017-07-19 |
Recalls
openFDA lists no recalls under a recalling firm named Quantitative Insights, Inc..
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 Quantitative Insights, Inc. have?
Quantitative Insights, Inc. has 1 FDA 510(k) clearance (first 2017, latest 2017), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Quantitative Insights, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Quantitative Insights, Inc.'s cleared 510(k)s is 114 days.
What devices does Quantitative Insights, Inc. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 1); POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, 1).
Has Quantitative Insights, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Quantitative Insights, Inc. Related entities may recall under other names.
Next steps
- See all 1 Quantitative Insights, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Quantitative Insights, Inc.'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.