510(k) K993599

DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 by Vidar Systems Corp. — Product Code LMA

K993599 is an FDA 510(k) premarket notification submitted by Vidar Systems Corp. for the device "DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019". The FDA issued a decision of Substantially Equivalent on January 18, 2000. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Vidar Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2000
Date Received
October 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitizer, Image, Radiological
Device Class
Class II
Regulation Number
892.2030
Review Panel
RA
Submission Type