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FDA 510(k)

VOYAGER COMPACT IMAGING SYSTEM

K-Number: K092182 · 2009-10-09

ApplicantArdent Sound, Inc.
Decision Date2009-10-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOYAGER COMPACT IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ardent Sound, Inc.. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K092182. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOYAGER COMPACT IMAGING SYSTEM?

VOYAGER COMPACT IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Ardent Sound, Inc.. The 510(k) number is K092182.

When did VOYAGER COMPACT IMAGING SYSTEM receive FDA 510(k) clearance?

VOYAGER COMPACT IMAGING SYSTEM received FDA 510(k) clearance on 2009-10-09, under 510(k) number K092182.

Who is the listed applicant for VOYAGER COMPACT IMAGING SYSTEM?

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

What is the FDA product code for VOYAGER COMPACT IMAGING SYSTEM?

The FDA product code for VOYAGER COMPACT IMAGING SYSTEM is IYO.

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 Ardent Sound, 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.

K060800SEEKER/SPARK ULTRASOUND SYSTEMK050551VOYAGER PERSONAL IMAGING DEVICE

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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