Cleared Traditional

K041831 - PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR

K041831 is an FDA 510(k) clearance for PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR, manufactured by Progeny, Inc.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K041831 · Progeny, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
33d
Days
Class 2
Risk

K041831 is an FDA 510(k) clearance for the PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Progeny, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on August 9, 2004 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041831

510(k) Number K041831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2004
Decision Date August 09, 2004
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - MUH System, X-ray, Extraoral Source, Digital

All 206
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K041831.
CDX DIGITAL X-RAY IMAGING SYSTEM
K042736 · Cnc Imaging, Inc. · Oct 2004
HDS INTRA-ORAL IMAGING SYSTEM
K042372 · Vatech Value Added Technology Co., Ltd. · Oct 2004
EV APAN DIGITAL, MODEL K1VSM2000
K041120 · Afp Imaging Corp. · Aug 2004
IMAGERAYI
K041580 · Henry Schein, Inc. · Jun 2004
DIGORA OPTIME (OR DIGORA ONTIME)
K041050 · Soredex Palodex Group OY · Jun 2004
X-VIEW
K024186 · Sometech Corporation · Apr 2004
K041831 · PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
Download PDF FDA Summary Progeny, Inc.