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FDA 510(k)

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L

K-Number: K913064 · 1991-09-16

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

Device Summary

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L 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 K913064. 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 XUD 150L?

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L 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 K913064.

When did SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L receive FDA 510(k) clearance?

SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L received FDA 510(k) clearance on 1991-09-16, under 510(k) number K913064.

Who is the listed applicant for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L?

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 XUD 150L?

The FDA product code for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L 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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