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510(k) K032350

INFRARED SCIENCES BREASTSCAN IR SYSTEM by Infrared Sciences Corp. — Product Code LHQ

K032350 is an FDA 510(k) premarket notification submitted by Infrared Sciences Corp. for the device "INFRARED SCIENCES BREASTSCAN IR SYSTEM". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
July 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type

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FDA data resources