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FDA 510(k)

SHIMADZU X-RAY TUBE STAND FH-31

K-Number: K895188 · 1989-09-22

ApplicantShimadzu Medical Systems
Decision Date1989-09-22
Product CodeIYB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU X-RAY TUBE STAND FH-31 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 1989-09-22 under 510(k) number K895188. The device is classified under product code IYB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIMADZU X-RAY TUBE STAND FH-31?

SHIMADZU X-RAY TUBE STAND FH-31 is a medical device that received FDA 510(k) clearance on 1989-09-22. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K895188.

When did SHIMADZU X-RAY TUBE STAND FH-31 receive FDA 510(k) clearance?

SHIMADZU X-RAY TUBE STAND FH-31 received FDA 510(k) clearance on 1989-09-22, under 510(k) number K895188.

Who is the listed applicant for SHIMADZU X-RAY TUBE STAND FH-31?

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 X-RAY TUBE STAND FH-31?

The FDA product code for SHIMADZU X-RAY TUBE STAND FH-31 is IYB.

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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: IYB)

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.

K935123SUPERSTAND 300Wuestec Medical, Inc.K946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000Scott Imaging Intl., Inc.K941017F/C/W TUBESTANDAcoma Medical Imaging, Inc.K941004CTS SYSTEMAcoma Medical Imaging, Inc.K940442MPR-814Xri, Inc.K935004MODEL ALPHA TS-2Dpa Consulting, 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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