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FDA 510(k)

VISION

K-Number: K042956 · 2005-03-11

ApplicantVarian Medical Systems, Inc.
Decision Date2005-03-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISION is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2005-03-11 under 510(k) number K042956. 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 VISION?

VISION is a medical device that received FDA 510(k) clearance on 2005-03-11. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K042956.

When did VISION receive FDA 510(k) clearance?

VISION received FDA 510(k) clearance on 2005-03-11, under 510(k) number K042956.

Who is the listed applicant for VISION?

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

What is the FDA product code for VISION?

The FDA product code for VISION is IYE.

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Related PubMed Literature

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.

PMID: 32442604The Vascular Implant Surveillance and Interventional Outcomes (VISION) Coordinated Registry Network: An effort to advance evidence evaluation for vascular devices.Journal of vascular surgery ()PMID: 28501378Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.Ophthalmology ()

Other records listing Varian Medical Systems, 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.

K261856Halcyon, Ethos Radiotherapy System (5.0)K260750Virtual Cone (1.0)K253026Respiratory Gating for Scanners (2.1)K252815ProBeam 360 Proton Therapy System v3.0K252304syngo.via RT Image Suite VC10K252977Halcyon, Ethos Radiotherapy System (5.0)

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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.

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