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)

SIMRITE VERIFICATION AND SIMULATION SYSTEM

K-Number: K885081 · 1989-03-22

ApplicantHaynes Radiation Ltd., Inc.
Decision Date1989-03-22
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMRITE VERIFICATION AND SIMULATION SYSTEM 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 1989-03-22 under 510(k) number K885081. 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 SIMRITE VERIFICATION AND SIMULATION SYSTEM?

SIMRITE VERIFICATION AND SIMULATION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Haynes Radiation Ltd., Inc.. The 510(k) number is K885081.

When did SIMRITE VERIFICATION AND SIMULATION SYSTEM receive FDA 510(k) clearance?

SIMRITE VERIFICATION AND SIMULATION SYSTEM received FDA 510(k) clearance on 1989-03-22, under 510(k) number K885081.

Who is the listed applicant for SIMRITE VERIFICATION AND SIMULATION SYSTEM?

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 SIMRITE VERIFICATION AND SIMULATION SYSTEM?

The FDA product code for SIMRITE VERIFICATION AND SIMULATION SYSTEM 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.

K834281RAD II SIMULATOR

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.

↑