Palomex Instrumentarium Corp.
FinlandFDA applicant, unverified
- Devices
- 2
What Palomex Instrumentarium Corp. makes
Palomex Instrumentarium Corp. manufactures mammographic X-ray devices for breast imaging and MRI systems, including the AcutScan Model 100, designed for detailed internal imaging.
Their devices are classified as Class II under US regulations and are authorised via FDA pathways, including 510(k) and PMA submissions. The company is based in the United States.
Catalogue
Mammograph Mammographic X-Ray Device Ref K872734
Regimes: 510(k) Registry: 510(k)Acutscan Model 100 Mri System Ref P860010
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Palomex Instrumentarium Corp. have in the registry?
The registry currently lists 2 devices for Palomex Instrumentarium Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Palomex Instrumentarium Corp.'s devices?
Among its 2 most recently registered devices, Palomex Instrumentarium Corp. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Palomex Instrumentarium Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Palomex Instrumentarium Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Palomex Instrumentarium Corp. in the registry?
The most recently registered devices listed for Palomex Instrumentarium Corp. include MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE and ACUTSCAN MODEL 100 MRI SYSTEM.