Flir Systems
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Flir Systems makes
FLIR Systems manufactures thermal imaging devices, specifically telethermographic cameras in Series A, E, S, and P configurations. These cameras detect and measure infrared radiation to capture thermal patterns, enabling applications in industrial inspections, search and rescue, and environmental monitoring.
The company’s thermal imaging cameras are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the United States, where FLIR Systems is based.
Catalogue
Telethermographic Camera, Series A, E, S And P Ref K033967
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Flir Systems, the earliest on 2009-01-30 and the most recent on 2009-03-10. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 10 Mar 2009 Z-1223-2009 Unclassified (pre-2012) Terminated MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.
- 30 Jan 2009 Z-0937-2009 Unclassified (pre-2012) Terminated LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product.
Frequently asked questions
How many devices does Flir Systems have in the registry?
The registry currently lists 1 device for Flir Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flir Systems's devices?
Among its 1 most recently registered device, Flir Systems has devices listed in FDA 510(k) (1 device).
What risk classes do Flir Systems's devices fall under?
Among its 1 most recently registered device, the classes recorded for Flir Systems's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Flir Systems?
FDA recall records list 2 recalls initiated by Flir Systems, the most recent initiated on 2009-03-10. 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 Flir Systems in the registry?
The most recently registered devices listed for Flir Systems include TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P.