Icrco, Inc.: FDA clearances and approvals
Icrco, Inc. has 5 FDA 510(k) clearances (first 2009, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time: 206 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 170 |
| 2013 | 1 | 252 |
| 2014 | 1 | 165 |
| 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 | 1 |
| OAS | X-Ray, Tomography, Computed, Dental | 1 | 1 |
Review panels
- Radiology (5)
Most recent Icrco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132499 | ICRCO CLARITY VIEWER | LLZ | 2014-01-21 | 165 |
| K122510 | ICRCO 3600M | MUE | 2013-04-26 | 252 |
| K120753 | CLARISCT | OAS | 2012-07-26 | 135 |
| K113449 | FUSION FLAT PANEL | MQB | 2012-06-14 | 206 |
| K082450 | IDR | MQB | 2009-06-30 | 309 |
Recalls
openFDA lists no recalls under a recalling firm named Icrco, 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 Icrco, Inc. have?
Icrco, Inc. has 5 FDA 510(k) clearances (first 2009, latest 2014), across 4 product codes in 1 review panel.
How long does FDA take to clear Icrco, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Icrco, Inc.'s cleared 510(k)s is 206 days.
What devices does Icrco, Inc. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); LLZ (System, Image Processing, Radiological, 1); MUE (Full Field Digital, System, X-Ray, Mammographic, 1).
Has Icrco, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Icrco, Inc. Related entities may recall under other names.
Next steps
- See all 5 Icrco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Icrco, 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.