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FDA 510(k)

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K991671 · 1999-06-18

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1999-06-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1999-06-18 under 510(k) number K991671. 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 HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM?

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K991671.

When did HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1999-06-18, under 510(k) number K991671.

Who is the listed applicant for HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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Other records listing Advanced Technology Laboratories, 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.

K021966Q LAB SOFTWAREK011224HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITYK002144MEDLINK DIAGNOSTIC OFFLINE WORKSTATIONK992470ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEMK961459LEVEL 10 HDIK935009PEGASUS

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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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