Image Data Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Image Data Corp.” (first 1990, latest 1993), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 122 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LMA | Digitizer, Image, Radiological | 1 | 1 |
Review panels
- Radiology (6)
Most recent Image Data Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931186 | PHOTOPHONE MULTIVIEW | LMD | 1993-11-22 | 258 |
| K931292 | MULTIVIEW FOR WINDOWS | LMD | 1993-07-29 | 139 |
| K931060 | STATVIEW | LMD | 1993-05-20 | 80 |
| K922267 | PHOTOPHONE(R) MULTI VIEW(TM) | LLZ | 1993-02-02 | 264 |
| K921527 | STATVIEW | LMD | 1992-06-24 | 82 |
| K896223 | PHOTOPHONE | LMA | 1990-02-12 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Image Data Corp..
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.
- Image Analysis, Inc. (9 510(k)s)
- Image Diagnostics, Inc. (3 510(k)s)
- Image Systems, Inc. (3 510(k)s)
- Image Diagnost International GmbH (2 510(k)s)
- Image Stream Medical, Inc. (2 510(k)s)
- Image Analysis Limited (1 510(k)s)
- Image Enhancements (1 510(k)s)
- Image Information Systems, Ltd. (1 510(k)s)
- Image Instruments GmbH (1 510(k)s)
- Image Medical, Inc. (1 510(k)s)
- Image of Hawaii (1 510(k)s)
- Image Premastering Services, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Image Data Corp.?
FDA lists 6 510(k) clearances under the applicant name “Image Data Corp.” (first 1990, latest 1993), across 3 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 Image Data Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Image Data Corp. is 122 days.
Which FDA product codes appear under Image Data Corp.?
The most frequent FDA product codes under this applicant name are LMD (System, Digital Image Communications, Radiological, 4); LLZ (System, Image Processing, Radiological, 1); LMA (Digitizer, Image, Radiological, 1).
Next steps
- See all 6 Image Data Corp. clearances with predicates and recalls
- Run predicate analysis for product code LMD, Image Data Corp.'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.