Manufacturer
Brainlab AGAutomatic Registration
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K234047
- Device name
- Automatic Registration
- Company
- Brainlab AG
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2023-12-21
- Decision date
- 2024-03-20
- Submission type
- Traditional
- Technology type
- Image Guided Surgery(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Navigation System
- Classification source
- AI classified
Indications for Use
Automatic Registration is a software device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems such as the Brainlab Spine & Trauma Navigation System. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.
Intended Use
Automatic Registration is a software device for image guided surgery intended to be used in combination with compatible Brainlab navigation systems such as the Brainlab Spine & Trauma Navigation System. Automatic Registration provides an image registration for intraoperatively acquired 3D CT/CBCT or fluoroscopic images.
Device Description
The Subject Device Automatic Registration is an accessory to the Brainlab Spine & Trauma Navigation System. It correlates intraoperatively acquired patient data (3D CT/CBCT or fluoroscopic images) to the surgical environment in order to provide a patient registration for subsequent use by the Brainlab Spine & Trauma Navigation application. The device includes the following software modules: Automatic Registration 2.6, Universal Atlas Performer 6.0, Universal Atlas Transfer Performer 6.0 and uses as well several hardware devices, mainly registration matrices, adhesive flat markers and a calibration phantom, for performing the registration.
Summary parsed at:2026-06-19 05:29:56 UTC
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Cited as predicate
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