FDA 510(k) clearance · back to tracker

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

Medhot Thermal Imaging, Inc. cleared K063047 on 2006-10-19, decision: substantially equivalent

K-number

K063047

Sponsor

Medhot Thermal Imaging, Inc.

Device

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

2006-10-19

Product code

LHQ

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.2980

Official FDA record

Open K063047on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.