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FDA 510(k)

ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)

K-Number: K961073 · 1997-02-19

ApplicantAtlantis Diagnostics Intl., Inc.
Decision Date1997-02-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) 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 1997-02-19 under 510(k) number K961073. 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 ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)?

ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) is a medical device that received FDA 510(k) clearance on 1997-02-19. The listed applicant is Atlantis Diagnostics Intl., Inc.. The 510(k) number is K961073.

When did ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) receive FDA 510(k) clearance?

ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) received FDA 510(k) clearance on 1997-02-19, under 510(k) number K961073.

Who is the listed applicant for ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)?

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 ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)?

The FDA product code for ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) 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.

K980860HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEMK936067ATLAS 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

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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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