International Remote Imaging Systems
Country not established
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Irispec Urine Chemistry Control Part A And B Ref K945913
Regimes: 510(k) Registry: 510(k)Aution Jet Aj-4270 Urine Analyzer Ref K030600
Regimes: 510(k) Registry: 510(k)Aution Max Ax-4280 Urinalysis System Ref K013783
Regimes: 510(k) Registry: 510(k)
FDA recalls
2005
- 29 Apr 2005 Z-0884-05 Unclassified (pre-2012) Terminated Nonconformance to performance specifications.
Frequently asked questions
How many devices does International Remote Imaging Systems have in the registry?
The registry currently lists 3 devices for International Remote Imaging Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list International Remote Imaging Systems's devices?
Among its 3 most recently registered devices, International Remote Imaging Systems has devices listed in FDA 510(k) (3 devices).
What risk classes do International Remote Imaging Systems's devices fall under?
Among its 3 most recently registered devices, the classes recorded for International Remote Imaging Systems's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for International Remote Imaging Systems?
FDA recall records list 1 recall initiated by International Remote Imaging Systems, the most recent initiated on 2005-04-29. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from International Remote Imaging Systems in the registry?
The most recently registered devices listed for International Remote Imaging Systems include IRISPEC URINE CHEMISTRY CONTROL PART A AND B, AUTION JET AJ-4270 URINE ANALYZER and AUTION MAX AX-4280 URINALYSIS SYSTEM.