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FDA 510(k)

OS-2000 OPTICAL SONOGRAPHY SYSTEM

K-Number: K001510 · 2000-11-30

ApplicantAdvanced Diagnostics, Inc.
Decision Date2000-11-30
Product CodeNCS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OS-2000 OPTICAL SONOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-11-30 under 510(k) number K001510. The device is classified under product code NCS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OS-2000 OPTICAL SONOGRAPHY SYSTEM?

OS-2000 OPTICAL SONOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-30. The listed applicant is Advanced Diagnostics, Inc.. The 510(k) number is K001510.

When did OS-2000 OPTICAL SONOGRAPHY SYSTEM receive FDA 510(k) clearance?

OS-2000 OPTICAL SONOGRAPHY SYSTEM received FDA 510(k) clearance on 2000-11-30, under 510(k) number K001510.

Who is the listed applicant for OS-2000 OPTICAL SONOGRAPHY SYSTEM?

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

What is the FDA product code for OS-2000 OPTICAL SONOGRAPHY SYSTEM?

The FDA product code for OS-2000 OPTICAL SONOGRAPHY SYSTEM is NCS.

Related Clinical Trials

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Other records listing Advanced Diagnostics, 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.

K023037MID STREAM PREGNANCY TESTK013886AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)K013291ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

Related Devices (Code: NCS)

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.

K013886AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)Advanced Diagnostics, Inc.K013291ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)Advanced Diagnostics, 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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