510(k) K021669

PHYSICIAN'S DESKTOP REVIEW by Adac Laboratories — Product Code LLZ

K021669 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "PHYSICIAN'S DESKTOP REVIEW". The FDA issued a decision of Substantially Equivalent on June 5, 2002. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Adac Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2002
Date Received
May 21, 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