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FDA 510(k)

TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM

K-Number: K881305 · 1988-10-19

ApplicantToshiba Medical Systems
Decision Date1988-10-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K881305. 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 TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM?

TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Toshiba Medical Systems. The 510(k) number is K881305.

When did TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM receive FDA 510(k) clearance?

TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM received FDA 510(k) clearance on 1988-10-19, under 510(k) number K881305.

Who is the listed applicant for TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM?

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

What is the FDA product code for TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM?

The FDA product code for TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM is JAK.

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Other records listing Toshiba 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.

K960948SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020AK954310BLA-800AK954309ANGIOREXK893750MRT-50A MOBILEK891453DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582VK890969TRANSESOPHAGEAL TRANSDUCER PEF-511SA

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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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