Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Dejarnette Research Systems — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

85 daysmedian FDA review time

102 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K974130	VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM	Dejarnette Research Systems	1998-01-29	87
K973421	IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR S	Dejarnette Research Systems	1997-12-05	86
K973422	LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT]	Dejarnette Research Systems	1997-10-28	48
K963861	LASERSHARE PRINT SPOOLER AND/OR SOFTWARE	Dejarnette Research Systems	1996-12-18	85
K963592	IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2	Dejarnette Research Systems	1996-11-07	59
K963594	IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFT	Dejarnette Research Systems	1996-11-07	59
K963628	IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR S	Dejarnette Research Systems	1996-11-07	57
K925793	TELESHARE 910	Dejarnette Research Systems	1993-02-26	102
K925284	IMAGESSSHARE 910	Dejarnette Research Systems	1993-01-21	93

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda