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Procedure Rehearsal Studio

by Simbionix, Ltd. 2 variants

510(k) K123269

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK123269 Date29 Jan 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
FDA applicant
Simbionix , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Procedure Rehearsal Studio is a Class 2 Radiology device with product code LLZ that processes patient CT scan data to create 3D anatomical models. This software enables clinicians to simulate, analyze, and evaluate preoperative surgical treatment options. It includes segmentation tools to generate 3D models that can be exported to Simbionix ANGIO.

The device is supplied as software and is used for creating patient-specific 3D digital models based on a patient's CT scans. It is FDA 510(k) cleared with number K123269, cleared through the Special 510(k) pathway after a 131-day FDA review. The device is manufactured by Simbionix, Ltd. and is intended for use in endovascular procedures.

Other devices from Simbionix, Ltd.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Procedure Rehearsal Studio used for?

    The Procedure Rehearsal Studio is a Class 2 Radiology device that processes patient CT scan data to create 3D anatomical models. It enables clinicians to simulate, analyze, and evaluate preoperative surgical treatment options for endovascular procedures.

  • How is the Procedure Rehearsal Studio supplied?

    The device is supplied as software that creates patient-specific 3D digital models based on a patient's CT scans. It includes segmentation tools that can generate 3D models exportable to Simbionix ANGIO.

  • What is the regulatory status of the Procedure Rehearsal Studio?

    The Procedure Rehearsal Studio is FDA 510(k) cleared with number K123269. It was cleared through the Special 510(k) pathway after a 131-day FDA review and is manufactured by Simbionix, Ltd.

  • What procedures can be planned using the Procedure Rehearsal Studio?

    The device is intended for use in endovascular procedures. It allows clinicians to simulate and evaluate various preoperative surgical treatment options by creating patient-specific 3D anatomical models from CT scan data.