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FDA 510(k)

MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)

K-Number: K012289 · 2001-08-14

ApplicantElekta Oncology Systems, Ltd.
Decision Date2001-08-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Oncology Systems, Ltd.. It received FDA 510(k) clearance on 2001-08-14 under 510(k) number K012289. 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 MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)?

MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) is a medical device that received FDA 510(k) clearance on 2001-08-14. The listed applicant is Elekta Oncology Systems, Ltd.. The 510(k) number is K012289.

When did MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) receive FDA 510(k) clearance?

MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) received FDA 510(k) clearance on 2001-08-14, under 510(k) number K012289.

Who is the listed applicant for MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)?

The FDA 510(k) record lists Elekta Oncology Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)?

The FDA product code for MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) 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 Elekta Oncology Systems, Ltd. 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.

K032996ELEKTA SYNERGY SYSTEMK982713RT DESKTOPK981790IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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