FDA 510(k)

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO

K-Number: K000359 · 2000-03-17

Decision Date2000-03-17

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO is the device name listed in this FDA 510(k) record. The listed applicant is Imatron, Inc.. It received FDA 510(k) clearance on 2000-03-17 under 510(k) number K000359. 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 EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO?

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO is a medical device that received FDA 510(k) clearance on 2000-03-17. The listed applicant is Imatron, Inc.. The 510(k) number is K000359.

When did EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO receive FDA 510(k) clearance?

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO received FDA 510(k) clearance on 2000-03-17, under 510(k) number K000359.

Who is the listed applicant for EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO?

The FDA 510(k) record lists Imatron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO?

The FDA product code for EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO is JAK.

Related Clinical Trials

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Other records listing Imatron, Inc. as applicant

K001550EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR K992740EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS K972903IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS K972879ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION K913352C-150 ULTRAFAST CT SCANNER K874934UNIVERSAL EXAMINATION TABLE

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Related Devices (Code: JAK)

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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.