510(k) K912382

MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 by Continental X-Ray Corp. — Product Code IXQ

K912382 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130". The FDA issued a decision of Substantially Equivalent on October 10, 1991. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
May 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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