Cleared Traditional

K033486 - GE PRECISION MPI

K033486 is an FDA 510(k) clearance for GE PRECISION MPI, manufactured by Nrt-Nordisk Rontgen Teknik A/S. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K033486 · Nrt-Nordisk Rontgen Teknik A/S · Radiology device
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Nov 2003
Decision
15d
Days
Class 2
Risk

K033486 is an FDA 510(k) clearance for the GE PRECISION MPI. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Nrt-Nordisk Rontgen Teknik A/S (Hasselager, DK). The FDA issued a Cleared decision on November 19, 2003 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Nrt-Nordisk Rontgen Teknik A/S devices

FDA 510(k) Submission Details - K033486

510(k) Number K033486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2003
Decision Date November 19, 2003
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 279
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K033486.
INNOVA 4100, INNOVA 3100
K042053 · Ge Medical Systems, Inc. · Aug 2004
AXIOM ARTIS U
K040675 · Siemens Medical Systems, Inc. · Jun 2004
ALLURA XPER FD20
K033737 · Philips Medical Systems North America, Inc. · Dec 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · Ge Medical Systems, Inc. · Oct 2003
INNOVA 3100
K031637 · GE Medical Systems · Aug 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · Philips Medical Systems, Inc. · Jul 2003