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FDA 510(k)

CADSTREAM VERSION 4.0

K-Number: K043216 · 2005-01-06

ApplicantConfirma, Inc.
Decision Date2005-01-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CADSTREAM VERSION 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Confirma, Inc.. It received FDA 510(k) clearance on 2005-01-06 under 510(k) number K043216. 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 4.0?

CADSTREAM VERSION 4.0 is a medical device that received FDA 510(k) clearance on 2005-01-06. The listed applicant is Confirma, Inc.. The 510(k) number is K043216.

When did CADSTREAM VERSION 4.0 receive FDA 510(k) clearance?

CADSTREAM VERSION 4.0 received FDA 510(k) clearance on 2005-01-06, under 510(k) number K043216.

Who is the listed applicant for CADSTREAM VERSION 4.0?

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 4.0?

The FDA product code for CADSTREAM VERSION 4.0 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 5K081556CADSTREAM, VERSION 5.0K071534CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTSK060547ACCESS BREAST COIL 4/SMSK052045ACCESS BREAST COILK041020CADSTREAM VERSION 3.1

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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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