Is2 Research, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Is2 Research, Inc.” (first 1998, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 83 days. 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 |
|---|---|---|
| 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 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 Is2 Research, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Is2 Research, Inc.” (first 1998, latest 2004), across 1 product code 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 Is2 Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Is2 Research, Inc. is 83 days.
Which FDA product codes appear under Is2 Research, Inc.?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 7).
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. 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.