Cleared Traditional

K011147 - CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)

K011147 is an FDA 510(k) clearance for CAVITAT ULTRASOUND BONE DENSITOMETER (C..., manufactured by Cavitat Medical Technologies, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K011147 · Cavitat Medical Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
305d
Days
Class 2
Risk

K011147 is an FDA 510(k) clearance for the CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT). Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Cavitat Medical Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on February 15, 2002 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K011147

510(k) Number K011147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date February 15, 2002
Days to Decision 305 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
198d slower than avg
Panel avg: 107d · This submission: 305d
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 189
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K011147.
MODIFICATION TO FOCUS
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DEGOTZEN SYNCHRO
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VERAVIEWEPOCS, MODEL VE
K013955 · J. Morita USA, Inc. · Feb 2002
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
K020070 · Progeny, Inc. · Feb 2002
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
K013176 · Afp Imaging Corp. · Oct 2001
K011147 · CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)
Download PDF FDA Summary Cavitat Medical Techn…