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FDA 510(k)

COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST

K-Number: K910212 · 1991-07-11

ApplicantAcoustic Imaging Technologies Corp.
Decision Date1991-07-11
Product CodeJYO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST is the device name listed in this FDA 510(k) record. The listed applicant is Acoustic Imaging Technologies Corp.. It received FDA 510(k) clearance on 1991-07-11 under 510(k) number K910212. The device is classified under product code JYO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST?

COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST is a medical device that received FDA 510(k) clearance on 1991-07-11. The listed applicant is Acoustic Imaging Technologies Corp.. The 510(k) number is K910212.

When did COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST receive FDA 510(k) clearance?

COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST received FDA 510(k) clearance on 1991-07-11, under 510(k) number K910212.

Who is the listed applicant for COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST?

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

What is the FDA product code for COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST?

The FDA product code for COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST is JYO.

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 Acoustic Imaging Technologies 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.

K923273AI 5200 DIAGNOSTIC ULTRASOUND SYSTEMK924458AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ

Related Devices (Code: JYO)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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