Cleared Traditional

K912249 - PATIENT DOSE MONITOR

K912249 is an FDA 510(k) clearance for PATIENT DOSE MONITOR, manufactured by Theta Systems, Inc.. The device is a Class 2 Radiology device with product code KPZ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K912249 · Theta Systems, Inc. · Radiology device
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Aug 1991
Decision
101d
Days
Class 2
Risk

K912249 is an FDA 510(k) clearance for the PATIENT DOSE MONITOR. Classified as Generator, High Voltage, X-ray, Therapeutic (product code KPZ), Class II - Special Controls.

Submitted by Theta Systems, Inc. (Melbourne, US). The FDA issued a Cleared decision on August 30, 1991 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Theta Systems, Inc. devices

FDA 510(k) Submission Details - K912249

510(k) Number K912249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date August 30, 1991
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPZ Device Classification - Class 2, Special Controls

Product Code KPZ Generator, High Voltage, X-ray, Therapeutic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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.