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FDA 510(k)

BIOPSY ACCESSORIES FOR ULTRASOUND PROBES

K-Number: K912088 · 1991-12-05

ApplicantBiosound, Inc.
Decision Date1991-12-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY ACCESSORIES FOR ULTRASOUND PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1991-12-05 under 510(k) number K912088. 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 BIOPSY ACCESSORIES FOR ULTRASOUND PROBES?

BIOPSY ACCESSORIES FOR ULTRASOUND PROBES is a medical device that received FDA 510(k) clearance on 1991-12-05. The listed applicant is Biosound, Inc.. The 510(k) number is K912088.

When did BIOPSY ACCESSORIES FOR ULTRASOUND PROBES receive FDA 510(k) clearance?

BIOPSY ACCESSORIES FOR ULTRASOUND PROBES received FDA 510(k) clearance on 1991-12-05, under 510(k) number K912088.

Who is the listed applicant for BIOPSY ACCESSORIES FOR ULTRASOUND PROBES?

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

What is the FDA product code for BIOPSY ACCESSORIES FOR ULTRASOUND PROBES?

The FDA product code for BIOPSY ACCESSORIES FOR ULTRASOUND PROBES is ITX.

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Other records listing Biosound, 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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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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