Intl. Remote Imaging Systems: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Intl. Remote Imaging Systems” (first 1982, latest 2002), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| KQO | Automated Urinalysis System | 4 | 4 |
| GKL | Counter, Cell, Automated (Particle Counter) | 3 | 3 |
| LKM | Counter, Urine Particle | 2 | 2 |
| GKZ | Counter, Differential Cell | 1 | 1 |
| IBJ | Light, Microscope | 1 | 1 |
| ICF | Crystal Violet For Histology | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
Review panels
- Hematology (6)
- Clinical Chemistry (5)
- Pathology (2)
- Microbiology (1)
Most recent Intl. Remote Imaging Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022774 | IQ 200 SYSTEM | LKM | 2002-10-21 | 61 |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | LKM | 2000-04-14 | 70 |
| K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION | KQO | 1997-08-25 | 80 |
| K953116 | WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER | GKZ | 1996-05-13 | 315 |
| K960054 | 900UDX URINE PATHOLOGY SYSTEM | KQO | 1996-03-22 | 78 |
| K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY | GKL | 1996-03-12 | 200 |
| K943463 | THE YELLOW IRIS | KQO | 1994-09-20 | 64 |
| K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY | GKL | 1994-03-30 | 194 |
| K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU | GKL | 1992-05-01 | 221 |
| K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 | JTS | 1989-06-13 | 36 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intl. Remote Imaging 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intl. Diagnostic Technology (29 510(k)s)
- Intl. Immunoassay Laboratories, Inc. (27 510(k)s)
- Intl. Medical, Inc. (17 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Business Machines (8 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Medical Equipment Corp. (6 510(k)s)
- Intl. Ophthalmic Industries Corp. (6 510(k)s)
- Intl. Trade Management Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Remote Imaging Systems?
FDA lists 14 510(k) clearances under the applicant name “Intl. Remote Imaging Systems” (first 1982, latest 2002), across 8 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intl. Remote Imaging Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Remote Imaging Systems is 81 days.
Which FDA product codes appear under Intl. Remote Imaging Systems?
The most frequent FDA product codes under this applicant name are KQO (Automated Urinalysis System, 4); GKL (Counter, Cell, Automated (Particle Counter), 3); LKM (Counter, Urine Particle, 2).
Next steps
- See all 14 Intl. Remote Imaging Systems clearances with predicates and recalls
- Run predicate analysis for product code KQO, Intl. Remote Imaging 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.