510(k) K915413

CAT-250B by Toshiba America Medical Systems, In.C — Product Code IZZ

K915413 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "CAT-250B". The FDA issued a decision of Substantially Equivalent on December 19, 1991. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1991
Date Received
December 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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