Cleared Traditional

K002258 - ULTRAGUIDE CT-GUIDE 1010

K002258 is an FDA 510(k) clearance for ULTRAGUIDE CT-GUIDE 1010, manufactured by Ultraguide , Ltd.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K002258 · Ultraguide , Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
14d
Days
Class 2
Risk

K002258 is an FDA 510(k) clearance for the ULTRAGUIDE CT-GUIDE 1010. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ultraguide , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on August 8, 2000 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002258

510(k) Number K002258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2000
Decision Date August 08, 2000
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 787
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K002258.
SOMATOM EMOTION MS
K003014 · Siemens Medical Solutions USA, Inc. · Oct 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · GE Medical Systems · Oct 2000
BOLUSPRO ULTRA
K002005 · Marconi Medical Systems, Inc. · Sep 2000
VSCORE WITH EKG SIGNAL GATING
K001682 · Vital Images, Inc. · Jun 2000
ULTRASIM CT SYSTEM
K001088 · Philips Medical Systems (Cleveland), Inc. · Jun 2000
PHILIPS CT SECURA MV
K000819 · Philips Medical Systems North America, Inc. · May 2000
K002258 · ULTRAGUIDE CT-GUIDE 1010
Download PDF FDA Summary Ultraguide , Ltd.