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FDA 510(k)

CARESTREAM PACS, MODEL CARESTREAM PACS VII

K-Number: K083673 · 2008-12-30

ApplicantCarestream Health, Inc.
Decision Date2008-12-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARESTREAM PACS, MODEL CARESTREAM PACS VII is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2008-12-30 under 510(k) number K083673. 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 CARESTREAM PACS, MODEL CARESTREAM PACS VII?

CARESTREAM PACS, MODEL CARESTREAM PACS VII is a medical device that received FDA 510(k) clearance on 2008-12-30. The listed applicant is Carestream Health, Inc.. The 510(k) number is K083673.

When did CARESTREAM PACS, MODEL CARESTREAM PACS VII receive FDA 510(k) clearance?

CARESTREAM PACS, MODEL CARESTREAM PACS VII received FDA 510(k) clearance on 2008-12-30, under 510(k) number K083673.

Who is the listed applicant for CARESTREAM PACS, MODEL CARESTREAM PACS VII?

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

What is the FDA product code for CARESTREAM PACS, MODEL CARESTREAM PACS VII?

The FDA product code for CARESTREAM PACS, MODEL CARESTREAM PACS VII is LLZ.

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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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