Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BRAINLAB CT/X-RAY LOCALIZER

K-Number: K954861 · 1996-08-05

ApplicantBrainlab Med. Computersysteme GmbH
Decision Date1996-08-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAINLAB CT/X-RAY LOCALIZER is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab Med. Computersysteme GmbH. It received FDA 510(k) clearance on 1996-08-05 under 510(k) number K954861. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINLAB CT/X-RAY LOCALIZER?

BRAINLAB CT/X-RAY LOCALIZER is a medical device that received FDA 510(k) clearance on 1996-08-05. The listed applicant is Brainlab Med. Computersysteme GmbH. The 510(k) number is K954861.

When did BRAINLAB CT/X-RAY LOCALIZER receive FDA 510(k) clearance?

BRAINLAB CT/X-RAY LOCALIZER received FDA 510(k) clearance on 1996-08-05, under 510(k) number K954861.

Who is the listed applicant for BRAINLAB CT/X-RAY LOCALIZER?

The FDA 510(k) record lists Brainlab Med. Computersysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAINLAB CT/X-RAY LOCALIZER?

The FDA product code for BRAINLAB CT/X-RAY LOCALIZER is IYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Brainlab Med. Computersysteme GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970586BRAINLAB MICRO MULTI-LEAF COLLIMATORK952390BRAINLAB STEROTATIC HEADRINGK945903BRAINLAB MASK SYSTEMK934657BRAINLAB LINAC HARDWARE

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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.

↑