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FDA 510(k)

CEILING SUSPENDED C-ARM SUPPORT MH-100

K-Number: K943545 · 1995-02-03

ApplicantShimadzu Medical Systems
Decision Date1995-02-03
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEILING SUSPENDED C-ARM SUPPORT MH-100 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 1995-02-03 under 510(k) number K943545. 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 CEILING SUSPENDED C-ARM SUPPORT MH-100?

CEILING SUSPENDED C-ARM SUPPORT MH-100 is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K943545.

When did CEILING SUSPENDED C-ARM SUPPORT MH-100 receive FDA 510(k) clearance?

CEILING SUSPENDED C-ARM SUPPORT MH-100 received FDA 510(k) clearance on 1995-02-03, under 510(k) number K943545.

Who is the listed applicant for CEILING SUSPENDED C-ARM SUPPORT MH-100?

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 CEILING SUSPENDED C-ARM SUPPORT MH-100?

The FDA product code for CEILING SUSPENDED C-ARM SUPPORT MH-100 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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