Cleared Traditional

K072665 - SUNIRAY 5.2

K072665 is an FDA 510(k) clearance for SUNIRAY 5.2, manufactured by Orangedental GmbH & Co. KG. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K072665 · Orangedental GmbH & Co. KG · Radiology device
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Oct 2007
Decision
12d
Days
Class 2
Risk

K072665 is an FDA 510(k) clearance for the SUNIRAY 5.2. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Orangedental GmbH & Co. KG (Biberach, DE). The FDA issued a Cleared decision on October 3, 2007 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Orangedental GmbH & Co. KG devices

FDA 510(k) Submission Details - K072665

510(k) Number K072665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date October 03, 2007
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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.

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