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FDA 510(k)

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I

K-Number: K040443 · 2004-06-16

ApplicantDome Imaging Systems, Inc.
Decision Date2004-06-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I is the device name listed in this FDA 510(k) record. The listed applicant is Dome Imaging Systems, Inc.. It received FDA 510(k) clearance on 2004-06-16 under 510(k) number K040443. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I?

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I is a medical device that received FDA 510(k) clearance on 2004-06-16. The listed applicant is Dome Imaging Systems, Inc.. The 510(k) number is K040443.

When did DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I receive FDA 510(k) clearance?

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I received FDA 510(k) clearance on 2004-06-16, under 510(k) number K040443.

Who is the listed applicant for DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I?

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

What is the FDA product code for DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I?

The FDA product code for DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I is LLZ.

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 Dome Imaging Systems, 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.

K983815PACSCACHE

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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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