FDA 510(k) clearance · back to tracker

RAYTEL DIGITAL IMAGING SYSTEMS

Olicon Imaging Systems, Inc. cleared K922164 on 1993-01-21, decision: substantially equivalent

K-number

K922164

Sponsor

Olicon Imaging Systems, Inc.

Device

RAYTEL DIGITAL IMAGING SYSTEMS

Class

Class I

Decision

Substantially Equivalent

Decision date

1993-01-21

Product code

LMD

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2020

Official FDA record

Open K922164on 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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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.