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)

VSS, VIRTUAL SIMULATION SYSTEM

K-Number: K980629 · 1998-05-06

ApplicantNucletron Corp.
Decision Date1998-05-06
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VSS, VIRTUAL SIMULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corp.. It received FDA 510(k) clearance on 1998-05-06 under 510(k) number K980629. 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 VSS, VIRTUAL SIMULATION SYSTEM?

VSS, VIRTUAL SIMULATION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-06. The listed applicant is Nucletron Corp.. The 510(k) number is K980629.

When did VSS, VIRTUAL SIMULATION SYSTEM receive FDA 510(k) clearance?

VSS, VIRTUAL SIMULATION SYSTEM received FDA 510(k) clearance on 1998-05-06, under 510(k) number K980629.

Who is the listed applicant for VSS, VIRTUAL SIMULATION SYSTEM?

The FDA 510(k) record lists Nucletron Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSS, VIRTUAL SIMULATION SYSTEM?

The FDA product code for VSS, VIRTUAL SIMULATION SYSTEM 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 Nucletron Corp. 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.

K092804MICROSELECTRON HDR V2, MODEL 105.999K091598LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERSK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALK041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001K041933MICROSELECTRON PDRK041719ONCENTRA-VISIR

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.

↑