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Ultraguide CT-Guide 1010

by Ultraguide, Ltd.

510(k) K002258

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 NumberK002258 Date8 Aug 2000ClearedStatusActive

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  • Withdrawn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
FDA applicant
Ultraguide , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Ultraguide CT-Guide 1010 is a computed tomography (CT) guidance system designed for use in radiology procedures. It integrates with CT imaging to provide real-time visualisation and precise localisation of anatomical structures or instruments during interventions, enhancing procedural accuracy and safety.

This device is intended for single-use in controlled medical environments, such as radiology departments, and is classified under the product code JAK. It is regulated under FDA 510(k) clearance (K002258) and falls under the classification of System, X-ray, Tomography, Computed. No additional sterility or MRI safety information is specified in the available data.

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