510(k) K191580

BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device by Varian Medical Systems, Inc. — Product Code JAQ

K191580 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device". The FDA issued a decision of Substantially Equivalent on Jul 8, 2019. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Varian Medical Systems, Inc. has 205 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 8, 2019
Date Received
Jun 14, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type
510(k)