510(k) K922098

CAG-02A by Toshiba America Medical Systems, In.C — Product Code KXJ

K922098 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "CAG-02A". The FDA issued a decision of Substantially Equivalent on Jul 27, 1992. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Toshiba America Medical Systems, In.C has 145 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 27, 1992
Date Received
May 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiologic
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K922098. Report a data issue: hello@regdatalab.com.