Imalux Corporation
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Imalux Corporation makes
Imalux Corporation manufactures medical imaging devices, specifically the IMALUX NIRIS IMAGING SYSTEM and the IMALUX OCT PROBE GUIDE.
These devices are Class II and listed in the FDA 510(k) registry. The company is based in the US.
Catalogue
Imalux Niris Imaging System Ref K042894
Regimes: 510(k) Registry: 510(k)Imalux Oct Probe Guide Ref K041077
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Imalux Corporation, initiated on 2011-12-22. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 22 Dec 2011 Z-0934-2012 Unclassified (pre-2012) Terminated During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
Frequently asked questions
How many devices does Imalux Corporation have in the registry?
The registry currently lists 2 devices for Imalux Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Imalux Corporation's devices?
Among its 2 most recently registered devices, Imalux Corporation has devices listed in FDA 510(k) (2 devices).
What risk classes do Imalux Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Imalux Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Imalux Corporation?
FDA recall records list 1 recall initiated by Imalux Corporation, the most recent initiated on 22 Dec 2011. 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 Imalux Corporation in the registry?
The most recently registered devices listed for Imalux Corporation include IMALUX NIRIS IMAGING SYSTEM and IMALUX OCT PROBE GUIDE.