510(k) K901654

MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE by Imt America, Inc. — Product Code IXR

K901654 is an FDA 510(k) premarket notification submitted by Imt America, Inc. for the device "MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on November 23, 1990. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Imt America, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1990
Date Received
April 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Tilting
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type