Cleared Traditional

K895034 - BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (FDA 510(k) Clearance)

Class I Radiology device.

K895034 · Yamato Medical Corp. · Radiology device
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Nov 1989
Decision
99d
Days
Class 1
Risk

K895034 is an FDA 510(k) clearance for the BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Yamato Medical Corp. (Shinjuku-Ku, Tokyo 169, JP). The FDA issued a Cleared decision on November 15, 1989 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1880 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Yamato Medical Corp. devices

Submission Details

510(k) Number K895034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date November 15, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 107d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXY Holder, Radiographic Cassette, Wall-mounted
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1880
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.