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FDA 510(k)

vRad PACS with Mammography

K-Number: K162145 · 2016-10-25

ApplicantVirtual Radiologic Corporation
Decision Date2016-10-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

vRad PACS with Mammography is the device name listed in this FDA 510(k) record. The listed applicant is Virtual Radiologic Corporation. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K162145. 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 vRad PACS with Mammography?

vRad PACS with Mammography is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Virtual Radiologic Corporation. The 510(k) number is K162145.

When did vRad PACS with Mammography receive FDA 510(k) clearance?

vRad PACS with Mammography received FDA 510(k) clearance on 2016-10-25, under 510(k) number K162145.

Who is the listed applicant for vRad PACS with Mammography?

The FDA 510(k) record lists Virtual Radiologic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for vRad PACS with Mammography?

The FDA product code for vRad PACS with Mammography is LLZ.

Other records listing Virtual Radiologic Corporation 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.

K241879vRad Viewer

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

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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