Electromek Diagnostic Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 11
What Electromek Diagnostic Systems, Inc. makes
Electromek Diagnostic Systems, Inc. manufactures medical imaging equipment, including three-phase and single-phase generators (e.g., MST 625, MSI 850, DXD 325, DXS 350), ceiling-mounted X-ray tube suspensions and hangers, C-arm fluoroscopy systems (e.g., POLARIX II, SIREMOBILE II), and fixed X-ray units (e.g., AMX 110, AMX 3). The company also produces mobile and fixed fluoroscopy imaging systems (e.g., FLUOROCON 300) and associated power supply solutions for radiographic procedures.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in diagnostic imaging and radiographic procedures, adhering to U.S. medical device compliance standards. The manufacturer is based in the United States.
Catalogue
Search and filter all 11 devicesFrequently asked questions
How many devices does Electromek Diagnostic Systems, Inc. have in the registry?
The registry currently lists 11 devices for Electromek Diagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Electromek Diagnostic Systems, Inc.'s devices?
Among its 11 most recently registered devices, Electromek Diagnostic Systems, Inc. has devices listed in FDA 510(k) (11 devices).
What risk classes do Electromek Diagnostic Systems, Inc.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Electromek Diagnostic Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Electromek Diagnostic Systems, Inc. in the registry?
The most recently registered devices listed for Electromek Diagnostic Systems, Inc. include G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN, G.E. XT CEILING TUBE SUSPENSION, G.E. 48-4 CEILING TUBEHANGER and G.E. MSI 850/850II/1250 THREE PHASE GENERATORS.