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FDA 510(k)

RADIANALYZER XPRESS

K-Number: K092105 · 2009-10-09

ApplicantRadi Medical Systems AB
Decision Date2009-10-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIANALYZER XPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Radi Medical Systems AB. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K092105. 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 RADIANALYZER XPRESS?

RADIANALYZER XPRESS is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Radi Medical Systems AB. The 510(k) number is K092105.

When did RADIANALYZER XPRESS receive FDA 510(k) clearance?

RADIANALYZER XPRESS received FDA 510(k) clearance on 2009-10-09, under 510(k) number K092105.

Who is the listed applicant for RADIANALYZER XPRESS?

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

What is the FDA product code for RADIANALYZER XPRESS?

The FDA product code for RADIANALYZER XPRESS is DQK.

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Other records listing Radi Medical Systems 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.

K123984QUANTIEN MEASUREMENT SYSTEMK080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVERK080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEMK062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306K042628MODIFICATION TO: RADIANALYZER, MODEL 12711K033291TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

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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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