Imex Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Imex Medical Systems, Inc.” (first 1983, latest 1998), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 154 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| JAF | Monitor, Ultrasonic, Nonfetal | 3 | 3 |
| JOP | Transducer, Ultrasonic | 3 | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| DQD | Stethoscope, Electronic | 1 | 1 |
| HEP | Monitor, Blood-Flow, Ultrasonic | 1 | 1 |
| HGH | Cannula, Suction, Uterine | 1 | 1 |
| IPL | Wheelchair, Standup | 1 | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Imex Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973556 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 | IYN | 1998-04-24 | 217 |
| K973562 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 | IYN | 1998-04-15 | 208 |
| K973336 | IMEX STETHODOP | JAF | 1998-02-05 | 154 |
| K970156 | IMEX FUTURALDOP PRO | IYO | 1997-04-04 | 78 |
| K942243 | IMEX 8000 PERSONAL CASCULAR LAB | IYO | 1995-11-03 | 543 |
| K944196 | IMWXDOP IR | JAF | 1995-05-12 | 256 |
| K942441 | IMEXDOP CT+ | JAF | 1994-08-23 | 92 |
| K910462 | POCKET DOP 3 | HEP | 1991-06-24 | 140 |
| K901593 | IMEX DOP-TONE II | KNG | 1990-07-02 | 88 |
| K896613 | FLAT VASCULAR PROBE | DPW | 1990-02-16 | 87 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Imex Medical Systems, 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.
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.
- Imex (1 510(k)s)
- Imex Health, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imex Medical Systems, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Imex Medical Systems, Inc.” (first 1983, latest 1998), across 11 product codes in 4 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 Imex Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imex Medical Systems, Inc. is 154 days.
Which FDA product codes appear under Imex Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); JAF (Monitor, Ultrasonic, Nonfetal, 3); JOP (Transducer, Ultrasonic, 3).
Next steps
- See all 19 Imex Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Imex Medical Systems, 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.