510(k) K874767

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11 by Shimadzu Precision Instruments, Inc. — Product Code JAK

K874767 is an FDA 510(k) premarket notification submitted by Shimadzu Precision Instruments, Inc. for the device "SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11". The FDA issued a decision of Substantially Equivalent on February 25, 1988. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Shimadzu Precision Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1988
Date Received
November 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type