Cleared Traditional

K041834 - ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

K041834 is an FDA 510(k) clearance for ADR PLUS SSXI IMAGING DEVICE FOR X-RAY ..., manufactured by Takara Belmont USA, Inc.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K041834 · Takara Belmont USA, Inc. · Radiology device
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Dec 2004
Decision
149d
Days
Class 2
Risk

K041834 is an FDA 510(k) clearance for the ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER C.... Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Takara Belmont USA, Inc. (West Cadwell, US). The FDA issued a Cleared decision on December 3, 2004 after a review of 149 days - within the typical 510(k) review window.

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: 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 Takara Belmont USA, Inc. devices

FDA 510(k) Submission Details - K041834

510(k) Number K041834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2004
Decision Date December 03, 2004
Days to Decision 149 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
42d slower than avg
Panel avg: 107d · This submission: 149d
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

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