Emi Therapy Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Emi Therapy Systems, Inc.” (first 1977, latest 1978), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 19 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| JAD | System, Therapeutic, X-Ray | 2 | 2 |
| IWB | System, Radiation Therapy, Radionuclide | 1 | 1 |
Review panels
- Radiology (5)
Most recent Emi Therapy Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K781084 | THERAPAX 150A | JAD | 1978-07-18 | 19 |
| K780948 | SYSTEM, PLANNING, TREATMENT | IWB | 1978-06-22 | 13 |
| K780027 | ACCELERATOR, LINEAR, MED. | IYE | 1978-01-26 | 22 |
| K771817 | EMI THERAPY SIMULATOR | JAD | 1978-01-13 | 109 |
| K771902 | EMI FOUR | IYE | 1977-10-19 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Emi Therapy 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Emi Therapy Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Emi Therapy Systems, Inc.” (first 1977, latest 1978), 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 Emi Therapy Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Emi Therapy Systems, Inc. is 19 days.
Which FDA product codes appear under Emi Therapy Systems, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 2); JAD (System, Therapeutic, X-Ray, 2); IWB (System, Radiation Therapy, Radionuclide, 1).
Next steps
- See all 5 Emi Therapy Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Emi Therapy 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.