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)

LINAC SCALPEL FLOORSTAND

K-Number: K964517 · 1997-04-01

ApplicantSurgical Navigation Technologies, Inc.
Decision Date1997-04-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINAC SCALPEL FLOORSTAND is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Navigation Technologies, Inc.. It received FDA 510(k) clearance on 1997-04-01 under 510(k) number K964517. 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 LINAC SCALPEL FLOORSTAND?

LINAC SCALPEL FLOORSTAND is a medical device that received FDA 510(k) clearance on 1997-04-01. The listed applicant is Surgical Navigation Technologies, Inc.. The 510(k) number is K964517.

When did LINAC SCALPEL FLOORSTAND receive FDA 510(k) clearance?

LINAC SCALPEL FLOORSTAND received FDA 510(k) clearance on 1997-04-01, under 510(k) number K964517.

Who is the listed applicant for LINAC SCALPEL FLOORSTAND?

The FDA 510(k) record lists Surgical Navigation Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINAC SCALPEL FLOORSTAND?

The FDA product code for LINAC SCALPEL FLOORSTAND 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 Surgical Navigation Technologies, Inc. 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.

K000246RADIOCAMERAS EXTRACRANIAL SYSTEMK994355RADIOCAMERAS SYSTEM HEAD/NECK APPLICATIONK992461STEALTHSTATION TREATMENT GUIDANCE PLATFORMK992927STEALTHSTATION TREATMENT GUIDANCE PLATFORMK993021METRX SYSTEMK992354SNT IMAGE ANALYSIS SYSTEM

View all 27 devices →

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.

↑