Automatic Registration
K-Number: K203679 · 2021-03-18
ApplicantBrainlab AG
Decision Date2021-03-18
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Automatic Registration is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2021-03-18 under approval number K203679. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Automatic Registration?
Automatic Registration is a medical device that received FDA 510(k) clearance on 2021-03-18. It is manufactured by Brainlab AG. The 510(k) number is K203679.
When was Automatic Registration approved by the FDA?
Automatic Registration received FDA 510(k) clearance on 2021-03-18, under approval number K203679.
What company makes Automatic Registration?
Automatic Registration is manufactured by Brainlab AG.
What is the FDA product code for Automatic Registration?
The FDA product code for Automatic Registration is OLO.
Other Devices by Brainlab AG
K153653DICOM Viewer
K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
K172820Microscope Navigation Software
K190250Microscope Navigation
K183605Spine & Trauma Navigation
Related Devices (Code: OLO)
K162375Envision 3D: Image Guidance System7D Surgical, Inc.
K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG
K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.
K160385Precision ScrewCryptych Pty, Ltd.
K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC
K153240Styrker OrthoMap Express Knee SystemStryker Corporate
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.