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FDA 510(k)

AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

K-Number: K013886 · 2002-05-10

ApplicantAdvanced Diagnostics, Inc.
Decision Date2002-05-10
Product CodeNCS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING 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 2002-05-10 under 510(k) number K013886. 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 AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)?

AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) is a medical device that received FDA 510(k) clearance on 2002-05-10. The listed applicant is Advanced Diagnostics, Inc.. The 510(k) number is K013886.

When did AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) receive FDA 510(k) clearance?

AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) received FDA 510(k) clearance on 2002-05-10, under 510(k) number K013886.

Who is the listed applicant for AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING 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 AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)?

The FDA product code for AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) is NCS.

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 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 TESTK013291ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)K001510OS-2000 OPTICAL SONOGRAPHY 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.

K013291ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)Advanced Diagnostics, Inc.K001510OS-2000 OPTICAL SONOGRAPHY SYSTEMAdvanced Diagnostics, 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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