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FDA 510(k)

ODYSSEY WORKSTATION

K-Number: K093092 · 2010-01-21

ApplicantStereotaxis, Inc.
Decision Date2010-01-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ODYSSEY WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2010-01-21 under 510(k) number K093092. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODYSSEY WORKSTATION?

ODYSSEY WORKSTATION is a medical device that received FDA 510(k) clearance on 2010-01-21. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K093092.

When did ODYSSEY WORKSTATION receive FDA 510(k) clearance?

ODYSSEY WORKSTATION received FDA 510(k) clearance on 2010-01-21, under 510(k) number K093092.

Who is the listed applicant for ODYSSEY WORKSTATION?

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

What is the FDA product code for ODYSSEY WORKSTATION?

The FDA product code for ODYSSEY WORKSTATION is DQK.

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Other records listing Stereotaxis, 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.

K262744GenesisX RMNK253473SynchronyK251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K250590MAGiC Sweep™ EP Mapping CatheterK193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemK192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, 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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