R2 Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “R2 Technology, Inc.” (first 2002, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 1 | 1 |
Review panels
- Radiology (5)
Most recent R2 Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051743 | R2 BREAST IMAGING WORKSTATION | LLZ | 2005-07-25 | 26 |
| K050667 | R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE | LLZ | 2005-03-29 | 14 |
| K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR | OEB | 2004-06-08 | 14 |
| K040028 | CA-1500 | LLZ | 2004-01-22 | 14 |
| K023003 | IMAGECHECKER-CT WORKSTATION | LLZ | 2002-11-20 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named R2 Technology, 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 R2 Technology, Inc.?
FDA lists 5 510(k) clearances under the applicant name “R2 Technology, Inc.” (first 2002, latest 2005), across 2 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 R2 Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R2 Technology, Inc. is 14 days.
Which FDA product codes appear under R2 Technology, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); OEB (Lung Computed Tomography System, Computer-Aided Detection, 1).
Next steps
- See all 5 R2 Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, R2 Technology, 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.