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)

RAD II SIMULATOR

K-Number: K834281 · 1983-12-29

ApplicantHaynes Radiation Ltd., Inc.
Decision Date1983-12-29
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAD II SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Haynes Radiation Ltd., Inc.. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K834281. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAD II SIMULATOR?

RAD II SIMULATOR is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Haynes Radiation Ltd., Inc.. The 510(k) number is K834281.

When did RAD II SIMULATOR receive FDA 510(k) clearance?

RAD II SIMULATOR received FDA 510(k) clearance on 1983-12-29, under 510(k) number K834281.

Who is the listed applicant for RAD II SIMULATOR?

The FDA 510(k) record lists Haynes Radiation Ltd., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAD II SIMULATOR?

The FDA product code for RAD II SIMULATOR is KPQ.

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 Haynes Radiation Ltd., 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.

K885081SIMRITE VERIFICATION AND SIMULATION SYSTEM

Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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.

↑