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FDA 510(k)

PRISM ACQUIRE PRISM PROCESS PRISM VIEW

K-Number: K122026 · 2012-09-21

ApplicantPrism Clinical Imaging, Inc.
Decision Date2012-09-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRISM ACQUIRE PRISM PROCESS PRISM VIEW is the device name listed in this FDA 510(k) record. The listed applicant is Prism Clinical Imaging, Inc.. It received FDA 510(k) clearance on 2012-09-21 under 510(k) number K122026. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISM ACQUIRE PRISM PROCESS PRISM VIEW?

PRISM ACQUIRE PRISM PROCESS PRISM VIEW is a medical device that received FDA 510(k) clearance on 2012-09-21. The listed applicant is Prism Clinical Imaging, Inc.. The 510(k) number is K122026.

When did PRISM ACQUIRE PRISM PROCESS PRISM VIEW receive FDA 510(k) clearance?

PRISM ACQUIRE PRISM PROCESS PRISM VIEW received FDA 510(k) clearance on 2012-09-21, under 510(k) number K122026.

Who is the listed applicant for PRISM ACQUIRE PRISM PROCESS PRISM VIEW?

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

What is the FDA product code for PRISM ACQUIRE PRISM PROCESS PRISM VIEW?

The FDA product code for PRISM ACQUIRE PRISM PROCESS PRISM VIEW is LNH.

Related Clinical Trials

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Other records listing Prism Clinical Imaging, 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.

K082964PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)

Related Devices (Code: LNH)

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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