3M Imtec
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What 3M Imtec makes
3M Imtec manufactures the ILUMA Vision Model Version 2.2, a device designed for ophthalmic imaging and diagnostic procedures, specifically for retinal imaging and analysis.
The ILUMA Vision Model Version 2.2 is classified as a Class II medical device in the United States and is listed in the FDA’s 510(k) registry. The company is based in the US.
Catalogue
Iluma Vision Model Version 2.2 Ref K094064
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by 3M Imtec, initiated on 2010-05-14. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 14 May 2010 Z-1703-2010 Unclassified (pre-2012) Terminated Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.
Frequently asked questions
How many devices does 3M Imtec have in the registry?
The registry currently lists 1 device for 3M Imtec. Devices recorded under merged duplicate company entries are counted once.
Which registries list 3M Imtec's devices?
Among its 1 most recently registered device, 3M Imtec has devices listed in FDA 510(k) (1 device).
What risk classes do 3M Imtec's devices fall under?
Among its 1 most recently registered device, the classes recorded for 3M Imtec's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for 3M Imtec?
FDA recall records list 1 recall initiated by 3M Imtec, the most recent initiated on 14 May 2010. 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 3M Imtec in the registry?
The most recently registered devices listed for 3M Imtec include ILUMA VISION MODEL VERSION 2.2.