FDA 510(k) clearance · back to tracker

MILTRA IMAGING INC., IMAGE VAULT

Mitra Imaging, Inc. cleared K974102 on 1998-01-20, decision: substantially equivalent

K-number

K974102

Sponsor

Mitra Imaging, Inc.

Device

MILTRA IMAGING INC., IMAGE VAULT

Class

Class I

Decision

Substantially Equivalent

Decision date

1998-01-20

Product code

LMD

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2020

Official FDA record

Open K974102on 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.