Cleared Special

K042361 - DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D

K042361 is an FDA 510(k) clearance for DIGITAL PORTABLE X-RAY UNITS, manufactured by Sedecal USA, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Special 510(k) pathway after a 29-day FDA review.

K042361 · Sedecal USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
29d
Days
Class 2
Risk

K042361 is an FDA 510(k) clearance for the DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sedecal USA, Inc. (Deer Field, US). The FDA issued a Cleared decision on September 29, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042361

510(k) Number K042361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2004
Decision Date September 29, 2004
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 229
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K042361.
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
K043002 · Sedecal., Sa. · Nov 2004
AMX5 AND AMX5D MOBILE X-RAY SYSTEMS
K042866 · Ge Healthcare Technologies · Nov 2004
PRACTIX CONVENIO
K042368 · Philips Medical Systems North America Co. · Oct 2004
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co. · Jul 2004
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
K041763 · Shimadzu Corp. · Jul 2004
PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF
K032628 · United Radiology Systems, Inc. · Feb 2004
K042361 · DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
Download PDF FDA Summary Sedecal USA, Inc.