FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE

K Number: K901654 · Decision Nov 23, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
5
Review Days
227

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Basic Information

Device Name
MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
K Number
K901654
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1980
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Imt America, Inc.
Date Received
April 10, 1990
Decision Date
November 23, 1990
Product Code
IXR
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IXR Table, Radiographic, Tilting

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Other Clearances by Imt America, Inc.

K Number Device Name
K903921 MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE
K903422 MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
K900193 MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT
K900194 MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT