Array Corp.
JP Last updated 22 Oct 2026
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- Devices
- 3
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Film Digitizer Model 2905 Ref K982785
Film Digitzer, Model 2908 Mammo Pro Ref K063424
Medical Image Digitizer, Model 2908 Ref K033637
What Array Corp. makes
Array Corp. manufactures medical film digitizers, including the Film Digitizer Model 2905, Film Digitizer Model 2908 MAMMO PRO, and Medical Image Digitizer Model 2908.
These devices are Class II medical devices listed in the FDA 510(k) registry. Array Corp. is based in the US.
Frequently asked questions
What does Array Corp. manufacture?
Array Corp. manufactures medical film digitizers, including the Film Digitizer Model 2905, Film Digitizer Model 2908 MAMMO PRO, and Medical Image Digitizer Model 2908. These devices are designed to convert medical film images into digital format for diagnostic purposes.
Where is Array Corp. based?
Array Corp. is based in the United States. The company operates within the US, developing and manufacturing medical imaging devices for healthcare facilities.
Which regulatory registries list Array Corp.'s devices?
Array Corp.'s devices are listed in the FDA 510(k) registry. This indicates that their products have been submitted to the FDA for clearance as medical devices, though each device must be individually authorized for market availability.
How are Array Corp.'s devices classified?
Array Corp.'s medical film digitizers are classified as Class II medical devices. Class II devices require general controls and special controls to ensure their safety and effectiveness, but they typically pose less risk than Class III devices.
Information
- Country
- JP