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FDA 510(k)

X-RAY VVA

K-Number: K112807 · 2012-02-27

ApplicantMedis Medical Imaging Systems BV
Decision Date2012-02-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY VVA is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2012-02-27 under 510(k) number K112807. 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 X-RAY VVA?

X-RAY VVA is a medical device that received FDA 510(k) clearance on 2012-02-27. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K112807.

When did X-RAY VVA receive FDA 510(k) clearance?

X-RAY VVA received FDA 510(k) clearance on 2012-02-27, under 510(k) number K112807.

Who is the listed applicant for X-RAY VVA?

The FDA 510(k) record lists Medis Medical Imaging Systems BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY VVA?

The FDA product code for X-RAY VVA is LLZ.

Other records listing Medis Medical Imaging Systems BV 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.

K182611Qangio XA 3DK073156QPLAQUE MRK062386QANGIO CTK050703QBRAINK042383RSA-CMSK041162ORTHO-CMS

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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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