510(k) K150707

IntelePACS by Intelerad Medical Systems Incorporated — Product Code LLZ

K150707 is an FDA 510(k) premarket notification submitted by Intelerad Medical Systems Incorporated for the device "IntelePACS". The FDA issued a decision of Substantially Equivalent on May 27, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Intelerad Medical Systems Incorporated has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2015
Date Received
March 19, 2015
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