Cleared Special

K153705 - PROcedure Rehearsal Studio

K153705 is an FDA 510(k) clearance for PROcedure Rehearsal Studio, manufactured by 3Dsystems, Simbionix Products. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 254-day FDA review.

K153705 · 3Dsystems, Simbionix Products · Radiology device
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Sep 2016
Decision
254d
Days
Class 2
Risk

K153705 is an FDA 510(k) clearance for the PROcedure Rehearsal Studio. 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 3Dsystems, Simbionix Products (Airport City, IL). The FDA issued a Cleared decision on September 2, 2016 after a review of 254 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Moderate-to-high 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 3Dsystems, Simbionix Products devices

FDA 510(k) Submission Details - K153705

510(k) Number K153705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date September 02, 2016
Days to Decision 254 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 107d · This submission: 254d
Pathway characteristics
Modification to existing cleared device.

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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