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FDA 510(k)

REMOTE CONTROLLED X-RAY DIAG. RSZ-200

K-Number: K905152 · 1990-12-11

ApplicantShimadzu Medical Systems
Decision Date1990-12-11
Product CodeIXR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REMOTE CONTROLLED X-RAY DIAG. RSZ-200 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 1990-12-11 under 510(k) number K905152. The device is classified under product code IXR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE CONTROLLED X-RAY DIAG. RSZ-200?

REMOTE CONTROLLED X-RAY DIAG. RSZ-200 is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K905152.

When did REMOTE CONTROLLED X-RAY DIAG. RSZ-200 receive FDA 510(k) clearance?

REMOTE CONTROLLED X-RAY DIAG. RSZ-200 received FDA 510(k) clearance on 1990-12-11, under 510(k) number K905152.

Who is the listed applicant for REMOTE CONTROLLED X-RAY DIAG. RSZ-200?

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 REMOTE CONTROLLED X-RAY DIAG. RSZ-200?

The FDA product code for REMOTE CONTROLLED X-RAY DIAG. RSZ-200 is IXR.

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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-1100K071289ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK071287ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PROK061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PROK061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

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Related Devices (Code: IXR)

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.

K000412VISION R/F TILTING TABLEVilla Sistemi Medicali S.P.A.K973039LEGACY/LEGACY-D TABLEGE Medical SystemsK971128CAP-35B III/CINE 275Jamieson Film Co.K970640PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.K965105ELECTROPHYSIOLOGY TILT TABLE MODEL #9660U.S. Imaging Tables, Inc.K965096FLUOROVIEW SERIES FLUOROSCOPIC TABLESU.S. Imaging Tables, Inc.

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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