Dynarad Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Dynarad Corp.” (first 1993, latest 2000), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 5 | 5 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
Review panels
- Radiology (9)
Most recent Dynarad Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000052 | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 | ITY | 2000-02-10 | 34 |
| K981267 | FACTS MONOBLOCK | IZX | 1998-05-06 | 29 |
| K973833 | CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL | IZL | 1997-12-30 | 84 |
| K932356 | NOVA XM2 | IZH | 1995-02-08 | 636 |
| K941363 | PHANTOM | IZL | 1994-07-20 | 121 |
| K932353 | HF-110A | IZL | 1994-01-31 | 263 |
| K932355 | 9150A, 1100F | IZL | 1993-08-03 | 82 |
| K932354 | 9170, 1170 | IZL | 1993-07-23 | 71 |
| K931725 | ALPHA II | EHD | 1993-07-14 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Dynarad Corp..
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 Dynarad Corp.?
FDA lists 9 510(k) clearances under the applicant name “Dynarad Corp.” (first 1993, latest 2000), 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 Dynarad Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynarad Corp. is 84 days.
Which FDA product codes appear under Dynarad Corp.?
The most frequent FDA product codes under this applicant name are IZL (System, X-Ray, Mobile, 5); EHD (Unit, X-Ray, Extraoral With Timer, 1); ITY (Assembly, Tube Housing, X-Ray, Diagnostic, 1).
Next steps
- See all 9 Dynarad Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Dynarad Corp.'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.