Cleared Traditional

REX PEDESTAL INTRA-ORAL X-RAY UNIT (K837491) - FDA 510(k) Clearance

K837491 · The Yoshida Dental Mfg. Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
74d
Days
-
Risk

K837491 is an FDA 510(k) clearance for the REX PEDESTAL INTRA-ORAL X-RAY UNIT.

Submitted by The Yoshida Dental Mfg. Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on June 13, 1983 after a review of 74 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.

View all The Yoshida Dental Mfg. Co., Ltd. devices

Submission Details

510(k) Number K837491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1983
Decision Date June 13, 1983
Days to Decision 74 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -