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Surgical Planner (SRP) BrainStorm

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201465

by Surgical Theater, Inc.

Identifiers

510(k) Number
K201465 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Surgical Planner (SRP) BrainStorm is a software interface and image segmentation system designed for transferring image information from CT, MR, or X-ray 3D Angiography medical scanners to an output file. It enhances epilepsy and functional care by providing advanced visualization and optimized operating room planning capabilities. The system integrates all patient data into a comprehensive 360° XR model, offering easy-to-understand insights for better surgical planning.

The device is intended for use in surgical planning by virtually simulating on patient-specific anatomy to improve situational awareness and customize each patient's surgical plan. It is supplied as a software system and is not specified as single-use or reusable. The Surgical Planner (SRP) BrainStorm has FDA 510(k) clearance with product code LLZ and was cleared on July 17, 2020.

Frequently asked questions

What is the Surgical Planner (SRP) BrainStorm used for?

The Surgical Planner (SRP) BrainStorm is a software interface designed for transferring image information from CT, MR, or X-ray 3D Angiography medical scanners to an output file. It enhances epilepsy and functional care by providing advanced visualization and optimized operating room planning capabilities.

How is the Surgical Planner (SRP) BrainStorm supplied?

The system is supplied as a software interface and is not specified as single-use or reusable. It integrates all patient data into a comprehensive 360° XR model, offering easy-to-understand insights for better surgical planning.

What regulatory status does the Surgical Planner (SRP) BrainStorm have?

The Surgical Planner (SRP) BrainStorm has FDA 510(k) clearance with product code LLZ and was cleared on July 17, 2020. It is intended for use in surgical planning by virtually simulating on patient-specific anatomy to improve situational awareness and customize each patient's surgical plan.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BrainSTORM - Surgical Theater, Surgical Planning - Surgical Theater, SuRgical Planner (SRP) BrainStorm (K201465) — FDA 510 (k) | Innolitics, SuRgical Planner (SRP) BrainStorm (K201465) - FDA 510 (k), PDF Surgical Theater, Inc. July 17, 2020 Mr. Kevin Murrock Sr. Director of ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgical Theater, Inc.

Sources (1)

  • FDA 510(k) K201465 24 fields · synced Oct 1, 2026