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FDA 510(k)

CEDARA I-RESPONSE CEDARA PET/CT

K-Number: K053301 · 2006-02-03

ApplicantCedara Software Corp.
Decision Date2006-02-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEDARA I-RESPONSE CEDARA PET/CT is the device name listed in this FDA 510(k) record. The listed applicant is Cedara Software Corp.. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K053301. 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 CEDARA I-RESPONSE CEDARA PET/CT?

CEDARA I-RESPONSE CEDARA PET/CT is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Cedara Software Corp.. The 510(k) number is K053301.

When did CEDARA I-RESPONSE CEDARA PET/CT receive FDA 510(k) clearance?

CEDARA I-RESPONSE CEDARA PET/CT received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053301.

Who is the listed applicant for CEDARA I-RESPONSE CEDARA PET/CT?

The FDA 510(k) record lists Cedara Software Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEDARA I-RESPONSE CEDARA PET/CT?

The FDA product code for CEDARA I-RESPONSE CEDARA PET/CT is LLZ.

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Other records listing Cedara Software Corp. 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.

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Related Devices (Code: LLZ)

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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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