Cleared Special

K043557 - MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS

K043557 is an FDA 510(k) clearance for MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X..., manufactured by Panoramic Corp.. The device is a Class 2 Radiology device with product code EHD cleared through the Special 510(k) pathway after a 17-day FDA review.

K043557 · Panoramic Corp. · Radiology device
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Jan 2005
Decision
17d
Days
Class 2
Risk

K043557 is an FDA 510(k) clearance for the MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Panoramic Corp. (Deer Field, US). The FDA issued a Cleared decision on January 13, 2005 after a review of 17 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. 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.

View all Panoramic Corp. devices

FDA 510(k) Submission Details - K043557

510(k) Number K043557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date January 13, 2005
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 136
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