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FDA 510(k)

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400

K-Number: K903941 · 1991-02-04

ApplicantShimadzu Medical Systems
Decision Date1991-02-04
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1991-02-04 under 510(k) number K903941. 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 SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400?

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K903941.

When did SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 receive FDA 510(k) clearance?

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 received FDA 510(k) clearance on 1991-02-04, under 510(k) number K903941.

Who is the listed applicant for SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400?

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

What is the FDA product code for SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400?

The FDA product code for SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 is IZI.

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Other records listing Shimadzu Medical Systems 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.

K082224DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONICK071291ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100K071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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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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