510(k) K063439

MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS by Mtd, Inc. — Product Code LLZ

K063439 is an FDA 510(k) premarket notification submitted by Mtd, Inc. for the device "MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS". The FDA issued a decision of Substantially Equivalent on January 22, 2007. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Mtd, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2007
Date Received
November 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type