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FDA 510(k)

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF

K-Number: K935487 · 1994-07-05

ApplicantShimadzu Corp.
Decision Date1994-07-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 1994-07-05 under 510(k) number K935487. 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-4800TF?

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF is a medical device that received FDA 510(k) clearance on 1994-07-05. The listed applicant is Shimadzu Corp.. The 510(k) number is K935487.

When did SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF receive FDA 510(k) clearance?

SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF received FDA 510(k) clearance on 1994-07-05, under 510(k) number K935487.

Who is the listed applicant for SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF?

The FDA 510(k) record lists Shimadzu Corp. 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-4800TF?

The FDA product code for SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF is JAK.

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Other records listing Shimadzu Corp. 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.

K101039SHIMADZU COLLIMATOR R-300K101036SHIMADZU COLLIMATOR R-20JK090578SHIMADZU COLLIMATOR R-30HK090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONK080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONK072006DAR-9400F

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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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