3Disc Americas: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “3Disc Americas” (first 2011, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 107 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 | 1 | 109 |
| 2014 | 2 | 107 |
| 2015 | 1 | 41 |
| 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (5)
Most recent 3Disc Americas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151687 | QuantorView | LLZ | 2015-08-03 | 41 |
| K133120 | COMPUTED RADIOGRAPHY SCANNER | MQB | 2014-01-15 | 107 |
| K133106 | COMPUTED RADIOGRAPHY SCANNER | MQB | 2014-01-15 | 107 |
| K131442 | FIRECR DENTALIMAGING SYSTEM | MUH | 2013-09-06 | 109 |
| K102619 | COMPUTED RADDIOGRAPHY SCANNER | MQB | 2011-05-13 | 242 |
Recalls
openFDA lists no recalls under a recalling firm named 3Disc Americas.
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 3Disc Americas?
FDA lists 5 510(k) clearances under the applicant name “3Disc Americas” (first 2011, latest 2015), 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 3Disc Americas?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3Disc Americas is 107 days.
Which FDA product codes appear under 3Disc Americas?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 3); LLZ (System, Image Processing, Radiological, 1); MUH (System, X-Ray, Extraoral Source, Digital, 1).
Next steps
- See all 5 3Disc Americas clearances with predicates and recalls
- Run predicate analysis for product code MQB, 3Disc Americas'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.