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FDA 510(k)

CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO

K-Number: K040468 · 2004-04-23

ApplicantCedara Software Corp.
Decision Date2004-04-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO 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 2004-04-23 under 510(k) number K040468. 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-SOFTVIEW AND CEDARA I-READMAMMO?

CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO is a medical device that received FDA 510(k) clearance on 2004-04-23. The listed applicant is Cedara Software Corp.. The 510(k) number is K040468.

When did CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO receive FDA 510(k) clearance?

CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO received FDA 510(k) clearance on 2004-04-23, under 510(k) number K040468.

Who is the listed applicant for CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO?

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-SOFTVIEW AND CEDARA I-READMAMMO?

The FDA product code for CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO 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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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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