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FDA 510(k)

SHIMADZU RADIOGRAPJHIC STAND BR-100

K-Number: K925169 · 1992-12-03

ApplicantShimadzu Medical Systems
Decision Date1992-12-03
Product CodeKPX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU RADIOGRAPJHIC STAND BR-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 1992-12-03 under 510(k) number K925169. The device is classified under product code KPX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIMADZU RADIOGRAPJHIC STAND BR-100?

SHIMADZU RADIOGRAPJHIC STAND BR-100 is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K925169.

When did SHIMADZU RADIOGRAPJHIC STAND BR-100 receive FDA 510(k) clearance?

SHIMADZU RADIOGRAPJHIC STAND BR-100 received FDA 510(k) clearance on 1992-12-03, under 510(k) number K925169.

Who is the listed applicant for SHIMADZU RADIOGRAPJHIC STAND BR-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 SHIMADZU RADIOGRAPJHIC STAND BR-100?

The FDA product code for SHIMADZU RADIOGRAPJHIC STAND BR-100 is KPX.

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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: KPX)

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.

K945635TRANS X-1000Canon USA, Inc.K935157ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBESRegulatory Consultants TO the Medical Device IndusK934850NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDSVictoreen, Inc.K933035BCM-600TXB C Medical , Ltd.K925598BUCKYMATIC AUTOMATIC CHEST FILM CHANGERAcoma Medical Imaging, Inc.K924423MWX-7440 HIGH SPEED BUCKYMidwest X-Ray Equipment Co.

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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