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FDA 510(k)

CADSTREAM, VERSION 5.0

K-Number: K081556 · 2009-02-02

ApplicantConfirma, Inc.
Decision Date2009-02-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CADSTREAM, VERSION 5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Confirma, Inc.. It received FDA 510(k) clearance on 2009-02-02 under 510(k) number K081556. 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 CADSTREAM, VERSION 5.0?

CADSTREAM, VERSION 5.0 is a medical device that received FDA 510(k) clearance on 2009-02-02. The listed applicant is Confirma, Inc.. The 510(k) number is K081556.

When did CADSTREAM, VERSION 5.0 receive FDA 510(k) clearance?

CADSTREAM, VERSION 5.0 received FDA 510(k) clearance on 2009-02-02, under 510(k) number K081556.

Who is the listed applicant for CADSTREAM, VERSION 5.0?

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

What is the FDA product code for CADSTREAM, VERSION 5.0?

The FDA product code for CADSTREAM, VERSION 5.0 is LLZ.

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Other records listing Confirma, 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.

K092954CADSTREAM VERSION 5K071534CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTSK060547ACCESS BREAST COIL 4/SMSK052045ACCESS BREAST COILK043216CADSTREAM VERSION 4.0K041020CADSTREAM VERSION 3.1

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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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