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FDA 510(k)

ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM

K-Number: K912416 · 1991-08-28

ApplicantXre Corp.
Decision Date1991-08-28
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K912416. 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 ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM?

ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Xre Corp.. The 510(k) number is K912416.

When did ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM receive FDA 510(k) clearance?

ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM received FDA 510(k) clearance on 1991-08-28, under 510(k) number K912416.

Who is the listed applicant for ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM?

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

What is the FDA product code for ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM?

The FDA product code for ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM is IZI.

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Other records listing Xre Corp. 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.

K973744UNICATH SP BI-PLANE (MODEL M269 & M289)K961193FULL FRAME ZOOM SYSTEMK960998XRE COLLIMATORK945449UNICATH LLU ANGIOGRAPHIC SYSTEMK936002CINEMAC QASK933460DVFX, MODEL M256

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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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