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FDA 510(k)

QCU ANALYTICAL SOFTWARE PACKAGE

K-Number: K011582 · 2001-07-31

ApplicantMedis Medical Imaging Systems BV
Decision Date2001-07-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QCU ANALYTICAL SOFTWARE PACKAGE 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 2001-07-31 under 510(k) number K011582. 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 QCU ANALYTICAL SOFTWARE PACKAGE?

QCU ANALYTICAL SOFTWARE PACKAGE is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K011582.

When did QCU ANALYTICAL SOFTWARE PACKAGE receive FDA 510(k) clearance?

QCU ANALYTICAL SOFTWARE PACKAGE received FDA 510(k) clearance on 2001-07-31, under 510(k) number K011582.

Who is the listed applicant for QCU ANALYTICAL SOFTWARE PACKAGE?

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 QCU ANALYTICAL SOFTWARE PACKAGE?

The FDA product code for QCU ANALYTICAL SOFTWARE PACKAGE is LLZ.

Related Clinical Trials

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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 3DK112807X-RAY VVAK073156QPLAQUE MRK062386QANGIO CTK050703QBRAINK042383RSA-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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