3D Line USA, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “3D Line USA, Inc.” (first 2000, latest 2004), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 146 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 |
| MUJ | System, Planning, Radiation Therapy Treatment | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
Review panels
Most recent 3D Line USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K034051 | DYNATRAC, COD. 50-1A | IYE | 2004-04-05 | 97 |
| K031281 | ERGO SRS | MUJ | 2003-12-23 | 245 |
| K031631 | STEREOTACTIC BODY FRAME, MODEL COD. 70-1A | IYE | 2003-07-18 | 52 |
| K013535 | EVTOOL MODEL # V. 1.0 | MUJ | 2002-01-18 | 87 |
| K011255 | 3D LINE STEROTACTIC HARDWARE ACCESSORIES | HAW | 2001-12-20 | 240 |
| K001163 | DMLC IV-ERGO | IXI | 2000-10-23 | 196 |
Recalls
openFDA lists no recalls under a recalling firm named 3D Line USA, 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 3D Line USA, Inc.?
FDA lists 6 510(k) clearances under the applicant name “3D Line USA, Inc.” (first 2000, latest 2004), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by 3D Line USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3D Line USA, Inc. is 146 days.
Which FDA product codes appear under 3D Line USA, Inc.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 2); MUJ (System, Planning, Radiation Therapy Treatment, 2); HAW (Neurological Stereotaxic Instrument, 1).
Next steps
- See all 6 3D Line USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, 3D Line USA, 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.