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FDA 510(k)

IMAGEGRID RADIOLOGY VIEWER SYSTEM

K-Number: K092949 · 2009-10-08

ApplicantCandelis, Inc.
Decision Date2009-10-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGEGRID RADIOLOGY VIEWER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Candelis, Inc.. It received FDA 510(k) clearance on 2009-10-08 under 510(k) number K092949. 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 IMAGEGRID RADIOLOGY VIEWER SYSTEM?

IMAGEGRID RADIOLOGY VIEWER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-08. The listed applicant is Candelis, Inc.. The 510(k) number is K092949.

When did IMAGEGRID RADIOLOGY VIEWER SYSTEM receive FDA 510(k) clearance?

IMAGEGRID RADIOLOGY VIEWER SYSTEM received FDA 510(k) clearance on 2009-10-08, under 510(k) number K092949.

Who is the listed applicant for IMAGEGRID RADIOLOGY VIEWER SYSTEM?

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

What is the FDA product code for IMAGEGRID RADIOLOGY VIEWER SYSTEM?

The FDA product code for IMAGEGRID RADIOLOGY VIEWER SYSTEM is LLZ.

Related Clinical Trials

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Other records listing Candelis, 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.

K262143ImageGrid StreamVueK111694ASTRAK080333IMAGEGRID

Related Devices (Code: LLZ)

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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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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