Andros Analyzers, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Andros Analyzers, Inc. makes
Andros Analyzers, Inc. manufactures medical imaging devices for vascular and airway analysis, including digital image processors, split-screen conversion systems, and airway adapters. Their portfolio includes systems for real-time vascular imaging, such as the Angiotec SPX Split Screen Dual Channel Scan Conversion system, and tools for managing and processing angiographic images, like the Angiotec Image Management System and ZX Digital Image Processor.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These systems are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Andros Analyzers Airway Adapter Ref K852463
Regimes: 510(k) Registry: 510(k)Angiotec Fmx-2220 System Ref K891485
Regimes: 510(k) Registry: 510(k)Angiotec Image Management System Ref K903806
Regimes: 510(k) Registry: 510(k)Angiotec Zx Digital Image Processor Ref K892869
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Andros Analyzers, Inc. have in the registry?
The registry currently lists 5 devices for Andros Analyzers, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Andros Analyzers, Inc.'s devices?
Among its 5 most recently registered devices, Andros Analyzers, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Andros Analyzers, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Andros Analyzers, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Andros Analyzers, Inc. in the registry?
The most recently registered devices listed for Andros Analyzers, Inc. include ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV., ANDROS ANALYZERS AIRWAY ADAPTER, ANGIOTEC FMX-2220 SYSTEM and ANGIOTEC IMAGE MANAGEMENT SYSTEM.