Cleared Special

K000551 - IMAGE X-70 PLUS DENTAL X-RAY UNIT

K000551 is the FDA 510(k) clearance for IMAGE X-70 PLUS DENTAL X-RAY UNIT by Medical Device Consultants, Inc.. It is a Class 2 Radiology device (product code EHD) cleared through the Special 510(k) pathway after a 27-day FDA review.

K000551 · Medical Device Consultants, Inc. · Radiology device
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Mar 2000
Decision
27d
Days
Class 2
Risk

K000551 is an FDA 510(k) clearance for the IMAGE X-70 PLUS DENTAL X-RAY UNIT. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Medical Device Consultants, Inc. (North Attleboro, US). The FDA issued a Cleared decision on March 16, 2000 after a review of 27 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 Medical Device Consultants, Inc. devices

Submission Details

510(k) Number K000551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date March 16, 2000
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 66
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