Cleared Traditional

K022630 - MODIFICATION TO FOCUS

K022630 is an FDA 510(k) clearance for MODIFICATION TO FOCUS, manufactured by Instrumentarium Corp.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K022630 · Instrumentarium Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
63d
Days
Class 2
Risk

K022630 is an FDA 510(k) clearance for the MODIFICATION TO FOCUS. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Instrumentarium Corp. (Milwaukee, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Instrumentarium Corp. devices

FDA 510(k) Submission Details - K022630

510(k) Number K022630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2002
Decision Date October 09, 2002
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 141
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K022630.
TROPHYPAN AND TROPHYPAN C
K033690 · Trophy Radiologie · Feb 2004
ORTHOPHOS XG DS/CEPH
K033073 · Sirona Dental Systems GmbH · Oct 2003
A/T X-RAY 70
K024285 · Air Techniques, Inc. · Apr 2003
VERAVIEWEPOCS, MODEL VE
K013955 · J. Morita USA, Inc. · Feb 2002
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · Planmeca Oy · Jun 2001
FOCUS
K001729 · Instrumentarium Corp. · Jul 2000