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)

STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM

K-Number: K940539 · 1994-03-16

ApplicantStandard Imaging, Inc.
Decision Date1994-03-16
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM is the device name listed in this FDA 510(k) record. The listed applicant is Standard Imaging, Inc.. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K940539. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM?

STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Standard Imaging, Inc.. The 510(k) number is K940539.

When did STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM receive FDA 510(k) clearance?

STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM received FDA 510(k) clearance on 1994-03-16, under 510(k) number K940539.

Who is the listed applicant for STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM?

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

What is the FDA product code for STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM?

The FDA product code for STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM is KPY.

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 Standard Imaging, 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.

K103193DOSEVIEW 3DK082773STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331K060532HDR 1000 PLUS WELL CHAMBER, MODEL 90008K042733STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEMK040688STANDARD IMAGING E.IMRT CALCULATORK013548STANDARD IMAGING IVB 1000 WELL CHAMBER

View all 10 devices →

Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.

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.

↑