Imation Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Imation Corp.” (first 1996, latest 1999), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| IXA | Cassette, Radiographic Film | 1 | 1 |
| IXW | Processor, Radiographic-Film, Automatic | 1 | 1 |
| LMA | Digitizer, Image, Radiological | 1 | 1 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Radiology (5)
Most recent Imation Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984252 | IMATION TRIMATIC DIGITAL SYSTEM | LMA | 1999-01-25 | 59 |
| K980722 | TRIMAX RADIOGRAPHIC CASSETTE | IXA | 1998-03-23 | 27 |
| K973303 | IMATION MODEL 9410 NETWORK INTERFACE | LMD | 1997-11-25 | 83 |
| K972163 | IMATION SE-196 LASER IMAGER | LMC | 1997-09-05 | 88 |
| K962750 | 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR | IXW | 1996-08-21 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Imation 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.
- Imation Enterprises Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imation Corp.?
FDA lists 5 510(k) clearances under the applicant name “Imation Corp.” (first 1996, latest 1999), across 5 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 Imation Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imation Corp. is 59 days.
Which FDA product codes appear under Imation Corp.?
The most frequent FDA product codes under this applicant name are IXA (Cassette, Radiographic Film, 1); IXW (Processor, Radiographic-Film, Automatic, 1); LMA (Digitizer, Image, Radiological, 1).
Next steps
- See all 5 Imation Corp. clearances with predicates and recalls
- Run predicate analysis for product code IXA, Imation 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.