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FDA 510(k)

VOYAGER PERSONAL IMAGING DEVICE

K-Number: K050551 · 2005-03-22

ApplicantArdent Sound, Inc.
Decision Date2005-03-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOYAGER PERSONAL IMAGING DEVICE 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 2005-03-22 under 510(k) number K050551. 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 PERSONAL IMAGING DEVICE?

VOYAGER PERSONAL IMAGING DEVICE is a medical device that received FDA 510(k) clearance on 2005-03-22. The listed applicant is Ardent Sound, Inc.. The 510(k) number is K050551.

When did VOYAGER PERSONAL IMAGING DEVICE receive FDA 510(k) clearance?

VOYAGER PERSONAL IMAGING DEVICE received FDA 510(k) clearance on 2005-03-22, under 510(k) number K050551.

Who is the listed applicant for VOYAGER PERSONAL IMAGING DEVICE?

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 PERSONAL IMAGING DEVICE?

The FDA product code for VOYAGER PERSONAL IMAGING DEVICE 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.

K092182VOYAGER COMPACT IMAGING SYSTEMK060800SEEKER/SPARK ULTRASOUND SYSTEM

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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