Is2 Research, Inc.: FDA clearances and approvals
Is2 Research, Inc. has 7 FDA 510(k) clearances (first 1998, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time: 83 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 7 | 7 |
Review panels
- Radiology (7)
Most recent Is2 Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040057 | MOBILE COMPACT DIGITAL CARDIAC CAMERA | KPS | 2004-02-02 | 20 |
| K033956 | MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC) | KPS | 2004-01-20 | 29 |
| K032779 | MODIFICATION TO: NUCAMMA RX | KPS | 2003-12-17 | 100 |
| K013667 | BCC GAMMA CAMERA | KPS | 2002-01-28 | 83 |
| K003882 | NUCAMMA BI90 | KPS | 2001-02-21 | 68 |
| K982045 | NUCAMMA RX | KPS | 1998-09-02 | 84 |
| K982044 | NUCAMMA R+ | KPS | 1998-09-02 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Is2 Research, 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 Is2 Research, Inc. have?
Is2 Research, Inc. has 7 FDA 510(k) clearances (first 1998, latest 2004), across 1 product code in 1 review panel.
How long does FDA take to clear Is2 Research, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Is2 Research, Inc.'s cleared 510(k)s is 83 days.
What devices does Is2 Research, Inc. make?
Its most frequent FDA product codes are KPS (System, Tomography, Computed, Emission, 7).
Has Is2 Research, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Is2 Research, Inc. Related entities may recall under other names.
Next steps
- See all 7 Is2 Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Is2 Research, 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.