FDA 510(k) clearance · back to tracker

MODEL 450 INFRARED IMAGING SYSTEM

Mitek , Inc. cleared K861534 on 1986-07-18, decision: substantially equivalent for some indications

K-number

K861534

Sponsor

Mitek , Inc.

Device

MODEL 450 INFRARED IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent for Some Indications

Decision date

1986-07-18

Product code

LHQ

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.2980

Official FDA record

Open K861534on 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.