510(k) K101641

AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 by Ag Digital Technology Corp. — Product Code LHQ

K101641 is an FDA 510(k) premarket notification submitted by Ag Digital Technology Corp. for the device "AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301". The FDA issued a decision of Substantially Equivalent on June 16, 2011. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Ag Digital Technology Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2011
Date Received
June 10, 2010
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