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FDA 510(k)

ADVANTAGE SIM 6.0

K-Number: K021780 · 2002-07-29

ApplicantGeneral Electric Medical Systems
Decision Date2002-07-29
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE SIM 6.0 is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems. It received FDA 510(k) clearance on 2002-07-29 under 510(k) number K021780. 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 ADVANTAGE SIM 6.0?

ADVANTAGE SIM 6.0 is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is General Electric Medical Systems. The 510(k) number is K021780.

When did ADVANTAGE SIM 6.0 receive FDA 510(k) clearance?

ADVANTAGE SIM 6.0 received FDA 510(k) clearance on 2002-07-29, under 510(k) number K021780.

Who is the listed applicant for ADVANTAGE SIM 6.0?

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

What is the FDA product code for ADVANTAGE SIM 6.0?

The FDA product code for ADVANTAGE SIM 6.0 is KPQ.

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 General Electric Medical Systems 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.

K052897GE DEFINIUM AMX 700, MODEL AMX 700K041521VOLUME VIEWER PLUSK041267CARDIQ ANALYSIS IIIK041270CT COLONOGRAPHY IIK014058ENTEGRA PE PERSONAL DIGITAL ASSISTANT

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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