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FDA 510(k)

ALPHAPOINT IMAGING SOFTWARE

K-Number: K120161 · 2012-04-13

ApplicantRadlogics, Inc.
Decision Date2012-04-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALPHAPOINT IMAGING SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Radlogics, Inc.. It received FDA 510(k) clearance on 2012-04-13 under 510(k) number K120161. 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 ALPHAPOINT IMAGING SOFTWARE?

ALPHAPOINT IMAGING SOFTWARE is a medical device that received FDA 510(k) clearance on 2012-04-13. The listed applicant is Radlogics, Inc.. The 510(k) number is K120161.

When did ALPHAPOINT IMAGING SOFTWARE receive FDA 510(k) clearance?

ALPHAPOINT IMAGING SOFTWARE received FDA 510(k) clearance on 2012-04-13, under 510(k) number K120161.

Who is the listed applicant for ALPHAPOINT IMAGING SOFTWARE?

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

What is the FDA product code for ALPHAPOINT IMAGING SOFTWARE?

The FDA product code for ALPHAPOINT IMAGING SOFTWARE is LLZ.

Related Clinical Trials

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Other records listing Radlogics, 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.

K193300AIMI-Triage CXR PTX

Related Devices (Code: LLZ)

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

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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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