Medical Device Manufacturer · US , Troy , IL

Electromek Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1990

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Electromek Diagnostic Systems, Inc. Radiology ✕

11 devices

1-11 of 11

Cleared Feb 13, 1991

G.E. DXD 325/350/350II/DXD 525/525II GENERATORS

Radiology · 232d

Cleared Dec 26, 1990

G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS

Radiology · 183d

Cleared Dec 19, 1990

G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN

Radiology · 176d

Cleared Dec 19, 1990

G.E. MSI 850/850II/1250 THREE PHASE GENERATORS

Radiology · 176d

Cleared Nov 13, 1990

G.E. POLARIX II C-ARM

Radiology · 140d

Cleared Nov 07, 1990

G.E. FLUOROCON 300 IMAGING SYSTEM

Radiology · 134d

Cleared Nov 06, 1990

SIEMEN'S SIREMOBILE II C-ARM

Radiology · 133d

Cleared Oct 29, 1990

G.E. 48-4 CEILING TUBEHANGER

Radiology · 125d

Cleared Oct 29, 1990

G.E. MONITROL 90 AND G.E. MONITROL 15

Radiology · 125d

Cleared Oct 26, 1990

G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS

Radiology · 122d

Cleared Oct 23, 1990

G.E. XT CEILING TUBE SUSPENSION

Radiology · 119d