510(k) K133324

SURESUBTRACTION LUNG by Toshiba Medical Systems Corporation, Japan — Product Code JAK

K133324 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Corporation, Japan for the device "SURESUBTRACTION LUNG". The FDA issued a decision of Substantially Equivalent on Sep 5, 2014. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Toshiba Medical Systems Corporation, Japan has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 5, 2014
Date Received
Oct 29, 2013
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
510(k)