Electromek Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Electromek Diagnostic Systems, Inc.” (first 1990, latest 1991), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 134 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 4 | 4 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 4 | 4 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Review panels
- Radiology (11)
Most recent Electromek Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902986 | G.E. DXD 325/350/350II/DXD 525/525II GENERATORS | IZO | 1991-02-13 | 232 |
| K902987 | G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS | IZO | 1990-12-26 | 183 |
| K902988 | G.E. MSI 850/850II/1250 THREE PHASE GENERATORS | IZO | 1990-12-19 | 176 |
| K902985 | G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN | IZO | 1990-12-19 | 176 |
| K902982 | G.E. POLARIX II C-ARM | JAA | 1990-11-13 | 140 |
| K902981 | G.E. FLUOROCON 300 IMAGING SYSTEM | JAA | 1990-11-07 | 134 |
| K902983 | SIEMEN'S SIREMOBILE II C-ARM | JAA | 1990-11-06 | 133 |
| K902989 | G.E. MONITROL 90 AND G.E. MONITROL 15 | IXR | 1990-10-29 | 125 |
| K902791 | G.E. 48-4 CEILING TUBEHANGER | KPR | 1990-10-29 | 125 |
| K902984 | G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS | IZL | 1990-10-26 | 122 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electromek Diagnostic 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 Electromek Diagnostic Systems, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Electromek Diagnostic Systems, Inc.” (first 1990, latest 1991), 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 Electromek Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electromek Diagnostic Systems, Inc. is 134 days.
Which FDA product codes appear under Electromek Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 4); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 4); IXR (Table, Radiographic, Tilting, 1).
Next steps
- See all 11 Electromek Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Electromek Diagnostic 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.