510(k) K122201

PROTURA COUCH SOFTWARE by Med-Tec, Inc. D/B/A Civco Medical Solutions — Product Code JAI

K122201 is an FDA 510(k) premarket notification submitted by Med-Tec, Inc. D/B/A Civco Medical Solutions for the device "PROTURA COUCH SOFTWARE". The FDA issued a decision of Substantially Equivalent on August 30, 2012. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Med-Tec, Inc. D/B/A Civco Medical Solutions has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2012
Date Received
July 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Couch, Radiation Therapy, Powered
Device Class
Class II
Regulation Number
892.5770
Review Panel
RA
Submission Type