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FDA 510(k)

HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K980860 · 1998-04-02

ApplicantAtlantis Diagnostics Intl., Inc.
Decision Date1998-04-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Atlantis Diagnostics Intl., Inc.. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980860. 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 1000 DIAGNOSTIC ULTRASOUND SYSTEM?

HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Atlantis Diagnostics Intl., Inc.. The 510(k) number is K980860.

When did HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980860.

Who is the listed applicant for HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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 Atlantis Diagnostics Intl., 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.

K961073ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)K936067ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM

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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