510(k) K945842

MOBILIX MOBILE X-RAY TABLE by GE Medical Systems — Product Code IXR

K945842 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "MOBILIX MOBILE X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on January 18, 1995. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. GE Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1995
Date Received
November 30, 1994
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