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FDA 510(k)

HELAX-IMCON, VERSION 1.0

K-Number: K982857 · 1998-11-04

ApplicantHelax AB
Decision Date1998-11-04
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HELAX-IMCON, VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Helax AB. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K982857. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELAX-IMCON, VERSION 1.0?

HELAX-IMCON, VERSION 1.0 is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Helax AB. The 510(k) number is K982857.

When did HELAX-IMCON, VERSION 1.0 receive FDA 510(k) clearance?

HELAX-IMCON, VERSION 1.0 received FDA 510(k) clearance on 1998-11-04, under 510(k) number K982857.

Who is the listed applicant for HELAX-IMCON, VERSION 1.0?

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-IMCON, VERSION 1.0?

The FDA product code for HELAX-IMCON, VERSION 1.0 is KPQ.

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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 SYSTEMK972617HELAX-VISIR

Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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