Cleared Traditional

K931717 - YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY

K931717 is an FDA 510(k) clearance for YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTA..., manufactured by Kaycor Intl., Ltd.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K931717 · Kaycor Intl., Ltd. · Radiology device
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Sep 1993
Decision
167d
Days
Class 2
Risk

K931717 is an FDA 510(k) clearance for the YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Kaycor Intl., Ltd. (Northbrook, US). The FDA issued a Cleared decision on September 20, 1993 after a review of 167 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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.

FDA 510(k) Submission Details - K931717

510(k) Number K931717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date September 20, 1993
Days to Decision 167 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 107d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - EAP Unit, X-ray, Intraoral

All 32
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K931717.
ORTHOPHOS 3/ ORTHOPHOS 3C
K936068 · Pelton & Crane Co. · Jul 1994
COMPUTED ORAL RADIOLOGY SYSTEM
K933455 · Schick Technologies, Inc. · Jan 1994
INTREX VSK INTERORAL DENTAL X-RAY UNIT
K931486 · Keystone X-Ray, Inc. · Nov 1993
INTREX INTERORAL DENTAL X-RAY UNIT
K930925 · Keystone X-Ray, Inc. · Jul 1993
IMAGE-X 70 INTRAORAL X-RAY SYSTEM
K930761 · Afp Imaging Corp. · May 1993
HEALTHPAK X-RAY SOX BARRIERS
K923307 · Healthpak, Inc. · Jan 1993
K931717 · YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY
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