FDA 510(k) clearance · back to tracker

BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM

Bales Scientific, Inc. cleared K850534 on 1985-02-27, decision: substantially equivalent

K-number

K850534

Sponsor

Bales Scientific, Inc.

Device

BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

1985-02-27

Product code

LHQ

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.2980

Official FDA record

Open K850534on 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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Drop K850534 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

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