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FDA 510(k)

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10

K-Number: K913062 · 1991-09-16

ApplicantShimadzu Medical Systems
Decision Date1991-09-16
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 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 1991-09-16 under 510(k) number K913062. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10?

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 is a medical device that received FDA 510(k) clearance on 1991-09-16. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K913062.

When did SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 receive FDA 510(k) clearance?

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 received FDA 510(k) clearance on 1991-09-16, under 510(k) number K913062.

Who is the listed applicant for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10?

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 HIGH VOLTAGE GENERATOR UD150B-10?

The FDA product code for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10 is IZO.

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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: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, 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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