Cleared Traditional

K041050 - DIGORA OPTIME (OR DIGORA ONTIME)

K041050 is an FDA 510(k) clearance for DIGORA OPTIME (OR DIGORA ONTIME), manufactured by Soredex Palodex Group OY. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K041050 · Soredex Palodex Group OY · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
54d
Days
Class 2
Risk

K041050 is an FDA 510(k) clearance for the DIGORA OPTIME (OR DIGORA ONTIME). Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Soredex Palodex Group OY (Helsinki, FI). The FDA issued a Cleared decision on June 15, 2004 after a review of 54 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 - K041050

510(k) Number K041050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date June 15, 2004
Days to Decision 54 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
53d faster than avg
Panel avg: 107d · This submission: 54d
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 K041050.
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K033248 · Hitachi Medical Systems America, Inc. · Oct 2003
K041050 · DIGORA OPTIME (OR DIGORA ONTIME)
Download PDF FDA Summary Soredex Palodex Group…