Imaging Sciences Intl., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Imaging Sciences Intl., Inc.” (first 1993, latest 2006), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (7)
Most recent Imaging Sciences Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061284 | I-CAT SCANNER | MUH | 2006-07-03 | 56 |
| K051980 | DVT SCANNER | JAK | 2005-08-19 | 29 |
| K041078 | SURGPLAN AND PANPLAN | LLZ | 2004-12-23 | 241 |
| K001248 | MULTI-PULSE 2000 | EHD | 2000-05-04 | 16 |
| K991518 | PANATOME | EHD | 1999-06-18 | 49 |
| K981466 | XR-910 | IZL | 1998-07-14 | 82 |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | IZF | 1993-08-23 | 137 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-03-19.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Imaging Dynamics Company , Ltd. (19 510(k)s)
- Imaging Biometrics, LLC (4 510(k)s)
- Imaging Engineering, LLC (4 510(k)s)
- Imaging Sciences International (3 510(k)s)
- Imaging Accessories, Inc. (2 510(k)s)
- Imaging Services, Inc. (2 510(k)s)
- Imaging Therapeutics, Inc. (2 510(k)s)
- Imaging and X-Ray Intl., Inc. (1 510(k)s)
- Imaging Concepts, Inc. (1 510(k)s)
- Imaging Dynamics Corp. (1 510(k)s)
- Imaging Dynamics Company Limited (1 510(k)s)
- Imaging Sciences International (Dba Gendex, LLC) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imaging Sciences Intl., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Imaging Sciences Intl., Inc.” (first 1993, latest 2006), across 6 product codes 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 Imaging Sciences Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imaging Sciences Intl., Inc. is 56 days.
Which FDA product codes appear under Imaging Sciences Intl., Inc.?
The most frequent FDA product codes under this applicant name are EHD (Unit, X-Ray, Extraoral With Timer, 2); IZF (System, X-Ray, Tomographic, 1); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 7 Imaging Sciences Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EHD, Imaging Sciences Intl., 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.