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)

HIGH DOSE RATE AFTERLOADER

K-Number: K945383 · 1995-02-15

ApplicantVarian Assoc., Inc.
Decision Date1995-02-15
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HIGH DOSE RATE AFTERLOADER is the device name listed in this FDA 510(k) record. The listed applicant is Varian Assoc., Inc.. It received FDA 510(k) clearance on 1995-02-15 under 510(k) number K945383. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH DOSE RATE AFTERLOADER?

HIGH DOSE RATE AFTERLOADER is a medical device that received FDA 510(k) clearance on 1995-02-15. The listed applicant is Varian Assoc., Inc.. The 510(k) number is K945383.

When did HIGH DOSE RATE AFTERLOADER receive FDA 510(k) clearance?

HIGH DOSE RATE AFTERLOADER received FDA 510(k) clearance on 1995-02-15, under 510(k) number K945383.

Who is the listed applicant for HIGH DOSE RATE AFTERLOADER?

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

What is the FDA product code for HIGH DOSE RATE AFTERLOADER?

The FDA product code for HIGH DOSE RATE AFTERLOADER is JAQ.

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 Varian Assoc., 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.

K000922PROTON VISIONK992762BRACHYVISION 6.0K992751SOMAVISIONK992753CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEMK990085MILLENNIUM MLC -120K980601VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER

View all 86 devices →

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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.

↑