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)
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.

View all Ultraguide , Ltd. devices

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

All 655
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K002258.
SOMATOM SMILE
K003152 · Siemens Medical Solutions USA, Inc. · Oct 2000
SOMATOM EMOTION MS
K003014 · Siemens Medical Solutions USA, Inc. · Oct 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · GE Medical Systems · Oct 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