Radformation, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under 2 spellings of the applicant name “Radformation, Inc.” (first 2016, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 106 days, against 116 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2016 | 1 | 90 |
| 2017 | 2 | 205 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 104 |
| 2021 | 0 | — |
| 2022 | 3 | 175 |
| 2023 | 1 | 32 |
| 2024 | 1 | 90 |
| 2025 | 1 | 101 |
| 2026 | 5 | 97 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Radformation, Inc. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 8 | 8 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 6 | 6 |
| MUJ | System, Planning, Radiation Therapy Treatment | 3 | 3 |
Review panels
- Radiology (17)
Most recent Radformation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261718 | EZFluence (RADEZ V2) | IYE | 2026-08-31 | 97 |
| K262452 | AutoContour (RADAC V6) | QKB | 2026-08-14 | 28 |
| K253962 | ClearCheck (RADCC V2.7) | IYE | 2026-04-03 | 113 |
| K260509 | AutoContour (RADAC V5) | QKB | 2026-03-19 | 30 |
| K252988 | ChartCheck (RADCH V1.6) | IYE | 2026-01-05 | 109 |
| K252863 | ClearCalc Model RADCA V2.6 | MUJ | 2025-12-19 | 101 |
| K242729 | AutoContour (Model RADAC V4) | QKB | 2024-12-09 | 90 |
| K230685 | AutoContour Model RADAC V3 | QKB | 2023-04-14 | 32 |
| K220598 | AutoContour Model RADAC V2 | QKB | 2022-08-24 | 175 |
| K220583 | ClearCheck Model RADCC V2 | IYE | 2022-08-23 | 175 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radformation, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Radformation, Inc. (16)
- Radformation (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radformation, Inc.?
FDA lists 17 510(k) clearances under 2 spellings of the applicant name “Radformation, Inc.” (first 2016, latest 2026), 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 Radformation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radformation, Inc. is 104 days. Since 2017: 106 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Radformation, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 8); QKB (Radiological Image Processing Software For Radiation Therapy, 6); MUJ (System, Planning, Radiation Therapy Treatment, 3).
Next steps
- See all 17 Radformation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Radformation, 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.