Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Remote Imaging Systems — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
221 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022774 | IQ 200 SYSTEM | Intl. Remote Imaging Systems | 2002-10-21 | 61 | 9 |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | 2000-04-14 | 70 | 0 |
| K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION | Intl. Remote Imaging Systems | 1997-08-25 | 80 | 0 |
| K953116 | WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER | Intl. Remote Imaging Systems | 1996-05-13 | 315 | 0 |
| K960054 | 900UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | 1996-03-22 | 78 | 0 |
| K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANA | Intl. Remote Imaging Systems | 1996-03-12 | 200 | 0 |
| K943463 | THE YELLOW IRIS | Intl. Remote Imaging Systems | 1994-09-20 | 64 | 0 |
| K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FL | Intl. Remote Imaging Systems | 1994-03-30 | 194 | 0 |
| K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU | Intl. Remote Imaging Systems | 1992-05-01 | 221 | 0 |
| K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 | Intl. Remote Imaging Systems | 1989-06-13 | 36 | 0 |
| K874207 | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION | Intl. Remote Imaging Systems | 1988-01-05 | 82 | 0 |
| K832713 | IRI SPEC URINALYSIS CONTROL | Intl. Remote Imaging Systems | 1983-12-22 | 132 | 1 |
| K830220 | YELLOW IRIS TM | Intl. Remote Imaging Systems | 1983-06-17 | 144 | 0 |
| K821503 | IRIS URINE STAIN | Intl. Remote Imaging Systems | 1982-06-03 | 15 | 0 |
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