510(k) K023434

DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM by Dorex, Inc. — Product Code LHQ

K023434 is an FDA 510(k) premarket notification submitted by Dorex, Inc. for the device "DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 14, 2002. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Dorex, Inc. has at least 1 other 510(k) clearance on record.