International Imaging Electronics: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “International Imaging Electronics” (first 1990, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | 13 | 13 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| EIA | Unit, Operative Dental | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
Most recent International Imaging Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972019 | PEFECT SHOT | EIA | 1997-07-03 | 32 |
| K970964 | MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM | LLZ | 1997-06-13 | 88 |
| K953165 | ULTRA COMPACT VIDEO IMAGER | LMC | 1996-05-07 | 305 |
| K950330 | DIGITAL IMAGE ACQUISITION SYSTEM | IYO | 1996-05-07 | 466 |
| K940332 | MODEL FORTY ULTRA COMPACT VIDEO IMAGER | LMC | 1994-06-08 | 135 |
| K934908 | FULL VIEW DIGITAL STORAGE SYSTEM | IYO | 1994-01-28 | 107 |
| K930755 | ULTRA COMPACT VIDEO IMAGER | LMC | 1993-09-28 | 228 |
| K930765 | ULTRA COMPACT VIDEO IMAGER | JAK | 1993-09-13 | 213 |
| K921992 | MP3000 SERIES III VIDEO IMAGER | LMC | 1992-07-10 | 79 |
| K920373 | MAESTRO DIGITAL VIDEO SYSTEM | IYO | 1992-06-24 | 147 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named International Imaging Electronics.
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.
- International Technidyne Corp. (48 510(k)s)
- International Biomedical (17 510(k)s)
- International Biophysics Corp. (14 510(k)s)
- International Medsurg Connection (13 510(k)s)
- International Medical Products, Inc. (9 510(k)s)
- International Newtech Development, Inc. (8 510(k)s)
- International Enzymes, Inc. (7 510(k)s)
- International Medical Industries, Inc. (7 510(k)s)
- International Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Regulatory Consultants (5 510(k)s)
- International Implant Seminars (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Imaging Electronics?
FDA lists 19 510(k) clearances under the applicant name “International Imaging Electronics” (first 1990, latest 1997), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by International Imaging Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Imaging Electronics is 62 days.
Which FDA product codes appear under International Imaging Electronics?
The most frequent FDA product codes under this applicant name are LMC (Camera, Multi Format, Radiological, 13); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); EIA (Unit, Operative Dental, 1).
Next steps
- See all 19 International Imaging Electronics clearances with predicates and recalls
- Run predicate analysis for product code LMC, International Imaging Electronics'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.