Atlas FDA

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

International Imaging Electronics — Predicate Candidate Screening

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

62 daysmedian FDA review time
305 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972019PEFECT SHOTInternational Imaging Electronics1997-07-03320
K970964MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEMInternational Imaging Electronics1997-06-13880
K950330DIGITAL IMAGE ACQUISITION SYSTEMInternational Imaging Electronics1996-05-074660
K953165ULTRA COMPACT VIDEO IMAGERInternational Imaging Electronics1996-05-073050
K940332MODEL FORTY ULTRA COMPACT VIDEO IMAGERInternational Imaging Electronics1994-06-081350
K934908FULL VIEW DIGITAL STORAGE SYSTEMInternational Imaging Electronics1994-01-281070
K930755ULTRA COMPACT VIDEO IMAGERInternational Imaging Electronics1993-09-282280
K930765ULTRA COMPACT VIDEO IMAGERInternational Imaging Electronics1993-09-132130
K921992MP3000 SERIES III VIDEO IMAGERInternational Imaging Electronics1992-07-10790
K920373MAESTRO DIGITAL VIDEO SYSTEMInternational Imaging Electronics1992-06-241470
K904897MODEL 400 ULTRA COMPACT VIDEO IMAGERInternational Imaging Electronics1990-11-20220
K904363MULTI FORMAT VIDEO IMAGER 600 PLUSInternational Imaging Electronics1990-11-13500
K900899MP3000 COMPACT VIDEO IMAGERInternational Imaging Electronics1990-04-30620
K900901MP4000 SERIES II COMPACT VIDEO IMAGERInternational Imaging Electronics1990-04-30620
K900900MP3000 SERIES II COMPACT VIDEO IMAGERInternational Imaging Electronics1990-04-30620
K9008966000 PLUS MULTI-FORMAT VIDEO IMAGERInternational Imaging Electronics1990-04-30620
K9008989000 ECONOMICAL 14 X 17 VIDEO IMAGERInternational Imaging Electronics1990-04-19510
K9008975000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI.International Imaging Electronics1990-04-19510
K896683COMPACT VIDEO IMAGER MP4000 SERIES IIIInternational Imaging Electronics1990-01-22550

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