Emi Medical, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Emi Medical, Inc.” (first 1977, latest 1979), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 7 | 7 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
Review panels
- Radiology (13)
Most recent Emi Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791429 | EMISONIC 4290 | IYO | 1979-09-21 | 57 |
| K781936 | SCANNER-EMI 7020 AND 7020R | JAK | 1978-12-04 | 14 |
| K781519 | EMI SIMULATOR REMOTE CONTROL CONSOLE | KPQ | 1978-09-14 | 13 |
| K781051 | EMISONIC 4201 | IYO | 1978-07-17 | 25 |
| K780995 | COMPUTERIZED AXIAL TOMOGRAPHY | IZF | 1978-06-22 | 8 |
| K780930 | 5543 INDEPENDENT VIEWING SYSTEM | JAK | 1978-06-14 | 8 |
| K780928 | CT5137 HIGH RESOLUTION OPTION | JAK | 1978-06-14 | 9 |
| K780737 | CT BLANKETS (BOLUS MATERIAL) | JAK | 1978-06-02 | 32 |
| K780736 | CT 5221 DOSE REDUCING COLLIMATORS | IZX | 1978-06-02 | 32 |
| K771978 | CTR 100L | JAK | 1977-11-23 | 37 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Emi Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Emi Medical, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Emi Medical, Inc.” (first 1977, latest 1979), 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 Emi Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Emi Medical, Inc. is 14 days.
Which FDA product codes appear under Emi Medical, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 7); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); IZF (System, X-Ray, Tomographic, 1).
Next steps
- See all 13 Emi Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Emi Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.