Medicsight: FDA clearances and approvals
Medicsight has 5 FDA 510(k) clearances (first 2003, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time: 37 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 2 | 2 |
| NWE | Colon Computed Tomography System, Computer Aided Detection | 1 | 1 |
Review panels
- Radiology (5)
Most recent Medicsight 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042674 | COLON CAR 1.2 | NWE | 2004-10-19 | 20 |
| K041807 | LUNG CAR 1.1 | OEB | 2004-07-22 | 16 |
| K033412 | MEDICLUNG, RELEASE 1 | OEB | 2003-12-30 | 64 |
| K032823 | MEDICHEART, MODEL RELEASE 1 | JAK | 2003-11-10 | 61 |
| K033102 | MEDIC COLON MODEL, RELEASE 1 | JAK | 2003-11-05 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Medicsight.
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 Medicsight have?
Medicsight has 5 FDA 510(k) clearances (first 2003, latest 2004), across 3 product codes in 1 review panel.
How long does FDA take to clear Medicsight's 510(k)s?
The median time from FDA receipt to decision across Medicsight's cleared 510(k)s is 37 days.
What devices does Medicsight make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 2); OEB (Lung Computed Tomography System, Computer-Aided Detection, 2); NWE (Colon Computed Tomography System, Computer Aided Detection, 1).
Has Medicsight had device recalls?
openFDA lists no recalls under a recalling firm name matching Medicsight. Related entities may recall under other names.
Next steps
- See all 5 Medicsight clearances with predicates and recalls
- Run predicate analysis for product code JAK, Medicsight'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.