Siemens Gammasonics, Inc.
United StatesFDA applicant, unverified
- Devices
- 53
What Siemens Gammasonics, Inc. makes
Siemens Gammasonics, Inc. manufactures nuclear medicine imaging systems, including gamma cameras, emission computed tomography (ECT) carbon fiber pallets, and digital imaging solutions like the Multispect 3 triple detector camera and Diacam gamma camera system. Their portfolio also includes digital subtraction angiography systems (e.g., Digitron 2), digital laser high-performance imagers (Digicam LHP), and specialized protocols such as the Digitron stenosis protocol. Image display workstations and PACS (Picture Archiving and Communication Systems) solutions are also part of their offerings, alongside carbon fiber pallets for imaging equipment.
The company’s devices are regulated under FDA Class I and Class II classifications, with many listed via the 510(k) pathway. Their products are primarily intended for the US market, where they comply with FDA requirements for nuclear imaging, digital radiography, and related diagnostic equipment. No additional regulatory bodies or international listings are specified.
Catalogue
Search and filter all 53 devicesShowing 1-50 of 53
Frequently asked questions
How many devices does Siemens Gammasonics, Inc. have in the registry?
The registry currently lists 53 devices for Siemens Gammasonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Siemens Gammasonics, Inc.'s devices?
Among its 50 most recently registered devices, Siemens Gammasonics, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Siemens Gammasonics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Siemens Gammasonics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Siemens Gammasonics, Inc. in the registry?
The most recently registered devices listed for Siemens Gammasonics, Inc. include MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM, SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI, CARBON FIBER PALLET and ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL.