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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

3D Systems, Inc.
Kim Torluemke

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2233
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K153705.
Scenium
K162339 · Siemens Medical Solutions USA, Inc. · Sep 2016
PixelShine
K161625 · Algomedica · Sep 2016
JiveX
K162008 · Visus Technology Transfer GmbH · Sep 2016
Restore PACS
K162141 · Xian Wingspan Electronic Technology Co., Ltd. · Sep 2016
ResolutionMD
K161130 · Calgary Scientific, Inc. · Aug 2016
WebPAX
K152949 · Heart Imaging Technologies, LLC · Aug 2016