510(k) K002782

HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION by Nuclear Diagnostics AB — Product Code LLZ

K002782 is an FDA 510(k) premarket notification submitted by Nuclear Diagnostics AB for the device "HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION". The FDA issued a decision of Substantially Equivalent on December 5, 2000. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Nuclear Diagnostics AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2000
Date Received
September 6, 2000
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