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FDA 510(k)

SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR

K-Number: K942731 · 1994-10-13

ApplicantShimadzu Corp.
Decision Date1994-10-13
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corp.. It received FDA 510(k) clearance on 1994-10-13 under 510(k) number K942731. 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 SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR?

SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR is a medical device that received FDA 510(k) clearance on 1994-10-13. The listed applicant is Shimadzu Corp.. The 510(k) number is K942731.

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

SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR received FDA 510(k) clearance on 1994-10-13, under 510(k) number K942731.

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

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 SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR?

The FDA product code for SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR is IZO.

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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: 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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