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)

DOSEVIEW 3D

K-Number: K103193 · 2010-12-27

ApplicantStandard Imaging, Inc.
Decision Date2010-12-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOSEVIEW 3D 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 2010-12-27 under 510(k) number K103193. 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 DOSEVIEW 3D?

DOSEVIEW 3D is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is Standard Imaging, Inc.. The 510(k) number is K103193.

When did DOSEVIEW 3D receive FDA 510(k) clearance?

DOSEVIEW 3D received FDA 510(k) clearance on 2010-12-27, under 510(k) number K103193.

Who is the listed applicant for DOSEVIEW 3D?

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 DOSEVIEW 3D?

The FDA product code for DOSEVIEW 3D 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 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.

K082773STANDARD 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 CHAMBERK002833MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER

View all 10 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.

↑