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FDA 510(k)

IMAGECHECKER-CT WORKSTATION

K-Number: K023003 · 2002-11-20

ApplicantR2 Technology, Inc.
Decision Date2002-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGECHECKER-CT WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is R2 Technology, Inc.. It received FDA 510(k) clearance on 2002-11-20 under 510(k) number K023003. 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 IMAGECHECKER-CT WORKSTATION?

IMAGECHECKER-CT WORKSTATION is a medical device that received FDA 510(k) clearance on 2002-11-20. The listed applicant is R2 Technology, Inc.. The 510(k) number is K023003.

When did IMAGECHECKER-CT WORKSTATION receive FDA 510(k) clearance?

IMAGECHECKER-CT WORKSTATION received FDA 510(k) clearance on 2002-11-20, under 510(k) number K023003.

Who is the listed applicant for IMAGECHECKER-CT WORKSTATION?

The FDA 510(k) record lists R2 Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGECHECKER-CT WORKSTATION?

The FDA product code for IMAGECHECKER-CT WORKSTATION is LLZ.

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Other records listing R2 Technology, 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.

K051743R2 BREAST IMAGING WORKSTATIONK050667R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWAREK041380IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATORK040028CA-1500

Related Devices (Code: LLZ)

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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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