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FDA 510(k)

SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE

K-Number: K891452 · 1989-06-07

ApplicantDiasonics, Inc.
Decision Date1989-06-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1989-06-07 under 510(k) number K891452. 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 SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE?

SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE is a medical device that received FDA 510(k) clearance on 1989-06-07. The listed applicant is Diasonics, Inc.. The 510(k) number is K891452.

When did SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE receive FDA 510(k) clearance?

SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE received FDA 510(k) clearance on 1989-06-07, under 510(k) number K891452.

Who is the listed applicant for SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE?

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

What is the FDA product code for SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE?

The FDA product code for SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE is IYO.

Related Clinical Trials

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Other records listing Diasonics, 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.

K962662VINGMED SOUND COLOR FLOW MAPPING SYSTEMK924079CFM-800 COLOR FLOW MAPPING SYSTEMK911435CPA/3.5 MHZ PROBEK905200SACA, 3.5 MHZ PROBEK903562CW DOPPLER 2.25 MHZ PROBEK903984CW DOPPLER/4.5 MHZ

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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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