Dejarnette Research Systems: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Dejarnette Research Systems” (first 1993, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | 7 | 7 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
Review panels
- Radiology (9)
Most recent Dejarnette Research Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974130 | VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE | LMD | 1998-01-29 | 87 |
| K973421 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} | LMD | 1997-12-05 | 86 |
| K973422 | LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]) | LMC | 1997-10-28 | 48 |
| K963861 | LASERSHARE PRINT SPOOLER AND/OR SOFTWARE | LMD | 1996-12-18 | 85 |
| K963628 | IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE | LMD | 1996-11-07 | 57 |
| K963594 | IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) | LMD | 1996-11-07 | 59 |
| K963592 | IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 | LMD | 1996-11-07 | 59 |
| K925793 | TELESHARE 910 | LLZ | 1993-02-26 | 102 |
| K925284 | IMAGESSSHARE 910 | LMD | 1993-01-21 | 93 |
Recalls
openFDA lists no recalls under a recalling firm named Dejarnette Research Systems.
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 Dejarnette Research Systems?
FDA lists 9 510(k) clearances under the applicant name “Dejarnette Research Systems” (first 1993, latest 1998), 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 Dejarnette Research Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dejarnette Research Systems is 85 days.
Which FDA product codes appear under Dejarnette Research Systems?
The most frequent FDA product codes under this applicant name are LMD (System, Digital Image Communications, Radiological, 7); LLZ (System, Image Processing, Radiological, 1); LMC (Camera, Multi Format, Radiological, 1).
Next steps
- See all 9 Dejarnette Research Systems clearances with predicates and recalls
- Run predicate analysis for product code LMD, Dejarnette Research Systems'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.