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FDA 510(k)

ISITE PACS, V 4. X

K-Number: K063267 · 2006-11-09

ApplicantStentor Inc., A Philips Medical Systems Co.
Decision Date2006-11-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISITE PACS, V 4. X is the device name listed in this FDA 510(k) record. The listed applicant is Stentor Inc., A Philips Medical Systems Co.. It received FDA 510(k) clearance on 2006-11-09 under 510(k) number K063267. 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 ISITE PACS, V 4. X?

ISITE PACS, V 4. X is a medical device that received FDA 510(k) clearance on 2006-11-09. The listed applicant is Stentor Inc., A Philips Medical Systems Co.. The 510(k) number is K063267.

When did ISITE PACS, V 4. X receive FDA 510(k) clearance?

ISITE PACS, V 4. X received FDA 510(k) clearance on 2006-11-09, under 510(k) number K063267.

Who is the listed applicant for ISITE PACS, V 4. X?

The FDA 510(k) record lists Stentor Inc., A Philips Medical Systems Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISITE PACS, V 4. X?

The FDA product code for ISITE PACS, V 4. X 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

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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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