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FDA 510(k)

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS

K-Number: K023970 · 2003-01-24

ApplicantMedis Medical Imaging Systems BV
Decision Date2003-01-24
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS 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 2003-01-24 under 510(k) number K023970. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS?

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K023970.

When did QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS receive FDA 510(k) clearance?

QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS received FDA 510(k) clearance on 2003-01-24, under 510(k) number K023970.

Who is the listed applicant for QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS?

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 QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS?

The FDA product code for QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS is IZI.

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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: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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