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FDA 510(k)

GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM

K-Number: K901545 · 1990-06-26

ApplicantToshiba America Medical Systems, In.C
Decision Date1990-06-26
Product CodeJWM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K901545. The device is classified under product code JWM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM?

GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K901545.

When did GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM receive FDA 510(k) clearance?

GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM received FDA 510(k) clearance on 1990-06-26, under 510(k) number K901545.

Who is the listed applicant for GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM?

The FDA product code for GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM is JWM.

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Other records listing Toshiba America Medical Systems, In.C as applicant

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Related Devices (Code: JWM)

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.

K914350ICON COMPUTER SYSTEMSiemens Gammasonics, Inc.K904599D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEMDigital Design, Inc.K903315ICONSiemens Gammasonics, Inc.K874473ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEMAdac LaboratoriesK873075ADAC MODEL ARC-5000, GAMMA CAMERAAdac LaboratoriesK851685DIGITAL GAMMA CAMERA GCA 601 EToshiba Medical Systems

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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