510(k) K052447

SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 by Analogic Corp. — Product Code JAK

K052447 is an FDA 510(k) premarket notification submitted by Analogic Corp. for the device "SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600". The FDA issued a decision of Substantially Equivalent on Sep 21, 2005. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Analogic Corp. has 31 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 21, 2005
Date Received
Sep 7, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type
510(k)