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CT9800 QUICK 3D #B7919DA

by General Electric Co.

510(k) K871859

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871859 Date12 Aug 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CT9800 QUICK 3D #B7919DA is a Class II radiology device with product code JAK, as defined by its FDA 510(k) clearance. It is a computed tomography (CT) scanner manufactured by General Electric Co.

The device was cleared through the traditional 510(k) pathway under K871859, with a decision date of August 12, 1987, following a 91-day FDA review. It is supplied as a non-sterile, reusable system intended for use in radiology settings, with no indications of single-use designation, MRI safety status, or specific storage requirements provided in the data.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CT9800 QUICK 3D #B7919DA used for?

    The CT9800 QUICK 3D #B7919DA is a computed tomography (CT) scanner intended for use in radiology settings, as indicated by its FDA 510(k) clearance and product code JAK, which falls under the radiology advisory committee classification.

  • Is the CT9800 QUICK 3D #B7919DA sterile or single-use?

    The device is supplied as a non-sterile, reusable system, with no indication of single-use designation in the provided data, meaning it is designed for repeated use after appropriate cleaning and reprocessing in clinical environments.

  • How was the CT9800 QUICK 3D #B7919DA cleared for market?

    The CT9800 QUICK 3D #B7919DA received FDA 510(k) clearance through the traditional pathway under K871859, with a decision date of August 12, 1987, following a 91-day review, and was found substantially equivalent to a predicate device.