Heuron Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Heuron Co., Ltd.” (first 2021, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 130 days. Since 2017 the median was 130 days, against 117 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 |
|---|---|---|
| 2021 | 1 | 87 |
| 2022 | 2 | 336 |
| 2023 | 1 | 130 |
| 2024 | 1 | 230 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Heuron Co., Ltd. took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 1 | 1 |
Review panels
- Radiology (5)
Most recent Heuron Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233247 | Heuron ICH | QAS | 2024-05-15 | 230 |
| K231642 | Veuron-Brain-pAb3 | LLZ | 2023-10-13 | 130 |
| K203279 | Veuron-Brain-mN1 | LNH | 2022-07-12 | 613 |
| K213801 | Veuron-Brain-pAb2 | LLZ | 2022-02-04 | 60 |
| K203142 | Veuron-Brain-pAb | LLZ | 2021-01-15 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Heuron Co., Ltd..
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.
Device clinical trials
An industry sponsor named Heuron Co., Ltd. is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT07546019: Evaluation of Heuron CTA for Detecting Suspected Large Vessel Occlusion Using Brain CT Angiography (Completed, started 2024-02-28)
- NCT05513794: Prospective Study for Neuromelanin Image Analysis (Completed, started 2022-11-02)
- NCT05572619: Evaluation of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images (Completed, started 2022-03-22)
- NCT04983927: Evaluation of Clinical Decision Support System for Scoring of ASPECT Score Using Brain CT Images (Completed, started 2021-08-11)
- NCT04983953: Evaluation of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images (Completed, started 2021-06-23)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Heuron Co., Ltd. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heuron Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Heuron Co., Ltd.” (first 2021, latest 2024), 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 Heuron Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heuron Co., Ltd. is 130 days. Since 2017: 130 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Heuron Co., Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 3); LNH (System, Nuclear Magnetic Resonance Imaging, 1); QAS (Radiological Computer-Assisted Triage And Notification Software, 1).
Next steps
- See all 5 Heuron Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Heuron Co., Ltd.'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.