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FDA 510(k)

V5M

K-Number: K942296 · 1995-03-02

ApplicantAcuson Corp.
Decision Date1995-03-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

V5M is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1995-03-02 under 510(k) number K942296. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V5M?

V5M is a medical device that received FDA 510(k) clearance on 1995-03-02. The listed applicant is Acuson Corp.. The 510(k) number is K942296.

When did V5M receive FDA 510(k) clearance?

V5M received FDA 510(k) clearance on 1995-03-02, under 510(k) number K942296.

Who is the listed applicant for V5M?

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

What is the FDA product code for V5M?

The FDA product code for V5M is ITX.

Other records listing Acuson Corp. 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.

K023772KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMK022896CSV12 SOFTWARE VIEWERK022567SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEMK021497CYPRESS ULTRASOUND SYSTEMK010950CYPRESS SYSTEMK0028073D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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