Cleared Traditional

K923307 - HEALTHPAK X-RAY SOX BARRIERS

K923307 is an FDA 510(k) clearance for HEALTHPAK X-RAY SOX BARRIERS, manufactured by Healthpak, Inc.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K923307 · Healthpak, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
258d
Days
Class 2
Risk

K923307 is an FDA 510(k) clearance for the HEALTHPAK X-RAY SOX BARRIERS. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Healthpak, Inc. (Chicago, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 258 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.

View all Healthpak, Inc. devices

FDA 510(k) Submission Details - K923307

510(k) Number K923307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1992
Decision Date January 21, 1993
Days to Decision 258 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 107d · This submission: 258d
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

Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K923307.
ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM
K960028 · Dentsply Intl. · Mar 1996
PORTARAY
K792535 · Siemens Corp. · Jan 1980
RAFLEX 70
K792437 · Mdt Corp., Inc. · Jan 1980
GE-700 INTRA ORAL X-RAY SYSTEM
K781630 · General Electric Co. · Dec 1978
X-RAY SYSTEM FOR DENTAL APPLICATION
K772184 · General Electric Co. · Dec 1977