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Iplan (iplan Cranial +5 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113732

by Brainlab AG

Identifiers

510(k) Number
K113732 FDA 510(k)
FDA Product Code
JAK FDA 510(k)
Models / Variants
iplan Cranial FDA 510(k)
Iplan Stereotaxy FDA 510(k)
Iplan Ent FDA 510(k)
Iplan Cmf FDA 510(k)
Iplan View FDA 510(k)
Iplan Spine FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Iplan is a software-based treatment planning application for medical professionals, including surgeons and radiologists. It imports medical imaging, such as DICOM, to perform image fusion, segmentation, and atlas-assisted visualization. The application has modules that support various procedures, including cranial, ENT, spine, and CMF procedures.

The Iplan application is supplied by Brainlab AG and has received FDA 510K clearance. It is used in radiology and is classified as a Class II device. The application is available in different modules, including Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan Cmf, Iplan View, and Iplan Spine, with the clearance number K113732.

Frequently asked questions

What procedures does Iplan support?

Iplan has modules that support cranial, ENT, spine, and CMF procedures, providing image fusion, segmentation, and atlas-assisted visualization for medical professionals.

Is Iplan supplied with any certifications?

Iplan has received FDA 510K clearance, classified as a Class II device, with the clearance number K113732, ensuring its safety and effectiveness for medical use.

How is Iplan classified and what is its product code?

Iplan is classified as a Class II device with a product code of JAK, indicating its intended use in radiology and treatment planning applications.

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: Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan Cmf, Iplan ..., Iplan (iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan Cmf, Iplan ..., Brainlab Iplan (iplan Cranial, Iplan Stereotaxy, Iplan Ent…, 510(k) K113732 — IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (1)

  • FDA 510(k) K113732 24 fields · synced Sep 24, 2026