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FDA 510(k)

HELAX-VISIR

K-Number: K972617 · 1997-10-01

ApplicantHelax AB
Decision Date1997-10-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HELAX-VISIR is the device name listed in this FDA 510(k) record. The listed applicant is Helax AB. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K972617. 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 HELAX-VISIR?

HELAX-VISIR is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Helax AB. The 510(k) number is K972617.

When did HELAX-VISIR receive FDA 510(k) clearance?

HELAX-VISIR received FDA 510(k) clearance on 1997-10-01, under 510(k) number K972617.

Who is the listed applicant for HELAX-VISIR?

The FDA 510(k) record lists Helax AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELAX-VISIR?

The FDA product code for HELAX-VISIR 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.

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Other records listing Helax AB 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.

K993766HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEMK982857HELAX-IMCON, VERSION 1.0

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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