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Aspen Imaging Healthcare, Inc

United Statesfrom the FDA registration address FDA establishment FEI 3012624817

Devices
8
Registrations
FDA
FDA recalls
0

Catalogue8

Newest first, rows 1-8 of 8

  • Apx-24

    None Registry: GUDID Class:II
  • AspenFDR

    None Registry: GUDID Class:II
  • AspenXDR

    None Registry: GUDID Class:II
  • Europa 90

    None Registry: GUDID Class:II
  • Europa 60

    None Registry: GUDID Class:II
  • Europa 85

    None Registry: GUDID Class:II
  • AspenView Ref K241425

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) Ref K241346

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

FDA FEI number
3012624817
Address
801 north Jupiter rd, Plano, TX, 75074

Frequently asked questions

How many devices does ASPEN IMAGING HEALTHCARE, INC have in the registry?

The registry currently lists 8 devices for ASPEN IMAGING HEALTHCARE, INC. Devices recorded under merged duplicate company entries are counted once.

Which registries list ASPEN IMAGING HEALTHCARE, INC's devices?

Among its 8 most recently registered devices, ASPEN IMAGING HEALTHCARE, INC has devices listed in FDA 510(k) (2 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do ASPEN IMAGING HEALTHCARE, INC's devices fall under?

Among its 8 most recently registered devices, the classes recorded for ASPEN IMAGING HEALTHCARE, INC's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from ASPEN IMAGING HEALTHCARE, INC in the registry?

The most recently registered devices listed for ASPEN IMAGING HEALTHCARE, INC include APX-24, AspenFDR, AspenXDR and EUROPA 90.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.