510(k) K020995

EFILM WORKSTATION WITH MODULES by Efilm Medical, Inc. — Product Code LLZ

K020995 is an FDA 510(k) premarket notification submitted by Efilm Medical, Inc. for the device "EFILM WORKSTATION WITH MODULES". The FDA issued a decision of Substantially Equivalent on April 12, 2002. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Efilm Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2002
Date Received
March 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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