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Mediso Medical Imaging Systems, Lttd.

Hungary Last updated 22 Oct 2026

Devices
20
Registries
EUDAMEDFDA 510(k)
FDA recalls
0

Catalogue20

EUDAMED certificates1

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 1662017-1 Supplemented

    Quality management system EU MDR

    Issued
    20 Apr 2026
    Expires
    9 Mar 2031
    Reason
    Add device or group

Related companies

What Mediso Medical Imaging Systems, Lttd. makes

Mediso Medical Imaging Systems produces hybrid imaging systems, including the InterView XP and InterView FUSION, designed for combined PET/CT and SPECT/CT applications. These devices integrate nuclear medicine imaging with computed tomography to enhance diagnostic accuracy for oncology, cardiology, and neurology.

The company’s portfolio is classified under FDA Class II devices and is authorised via the 510(k) pathway. These systems are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Mediso Medical Imaging Systems, Lttd. have in the registry?

The registry currently lists 20 devices for Mediso Medical Imaging Systems, Lttd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mediso Medical Imaging Systems, Lttd.'s devices?

Among its 20 most recently registered devices, Mediso Medical Imaging Systems, Lttd. has devices listed in EUDAMED (18 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Mediso Medical Imaging Systems, Lttd.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Mediso Medical Imaging Systems, Lttd.'s devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Mediso Medical Imaging Systems, Lttd.?

EUDAMED lists 1 certificate for Mediso Medical Imaging Systems, Lttd. (quality management system) under MDR. The most recent was issued on 2026-04-20.

What are the newest devices from Mediso Medical Imaging Systems, Lttd. in the registry?

The most recently registered devices listed for Mediso Medical Imaging Systems, Lttd. include Nucline TH-45 (Gamma Camera), AnyScan TRIO-TheraMAX SPECT/CT, AnyScan DUO SPECT/CT/PET and AnyScan TRIO SPECT/CT.

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

Information

Address
3., Laborc , Budapest, Hungary
PRRC contact
Daniel Cser
EUDAMED SRN
HU-MF-000008325