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FDA 510(k)

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX

K-Number: K911501 · 1991-07-17

ApplicantShimadzu Medical Systems
Decision Date1991-07-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX 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 1991-07-17 under 510(k) number K911501. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX?

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K911501.

When did SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX receive FDA 510(k) clearance?

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX received FDA 510(k) clearance on 1991-07-17, under 510(k) number K911501.

Who is the listed applicant for SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX?

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 WHOLE BODY X-RAY CT SCANNER SCT-5000TX?

The FDA product code for SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX is JAK.

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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: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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