Cleared Traditional

K828325 - YOSHIDA/KAYCOR X-70 X-RAY UNIT (FDA 510(k) Clearance)

K828325 · The Yoshida Dental Mfg. Co., Ltd. · Radiology device
Oct 1982
Decision
23d
Days
-
Risk

K828325 is an FDA 510(k) clearance for the YOSHIDA/KAYCOR X-70 X-RAY UNIT.

Submitted by The Yoshida Dental Mfg. Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on October 21, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K828325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1982
Decision Date October 21, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -