Cleared Traditional

K896024 - MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE

K896024 is an FDA 510(k) clearance for MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE, manufactured by Mdt Diagnostic Co.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K896024 · Mdt Diagnostic Co. · Radiology device
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Jan 1990
Decision
98d
Days
Class 2
Risk

K896024 is an FDA 510(k) clearance for the MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Mdt Diagnostic Co. (Rochester, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 98 days - within the typical 510(k) review window.

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 Mdt Diagnostic Co. devices

FDA 510(k) Submission Details - K896024

510(k) Number K896024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date January 22, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
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 15
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K896024.
ATLANTIS
K953936 · Trophy Radiologie · Dec 1995
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
K950533 · Trophy Radiologie · Jun 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995
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