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FDA 510(k)

DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE

K-Number: K032443 · 2004-02-20

ApplicantShimadzu Corp.
Decision Date2004-02-20
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K032443. 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 DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE?

DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Shimadzu Corp.. The 510(k) number is K032443.

When did DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE receive FDA 510(k) clearance?

DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE received FDA 510(k) clearance on 2004-02-20, under 510(k) number K032443.

Who is the listed applicant for DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE?

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

What is the FDA product code for DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE?

The FDA product code for DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE is IZI.

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Other records listing Shimadzu Corp. as applicant

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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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