Cleared Traditional

K003238 - SOLID STATE X-RAY IMAGING DEVICES

K003238 is an FDA 510(k) clearance for SOLID STATE X-RAY IMAGING DEVICES, manufactured by Cares Built, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K003238 · Cares Built, Inc. · Radiology device
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Oct 2001
Decision
349d
Days
Class 2
Risk

K003238 is an FDA 510(k) clearance for the SOLID STATE X-RAY IMAGING DEVICES. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Cares Built, Inc. (Keyport, US). The FDA issued a Cleared decision on October 1, 2001 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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.

View all Cares Built, Inc. devices

FDA 510(k) Submission Details - K003238

510(k) Number K003238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2000
Decision Date October 01, 2001
Days to Decision 349 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 107d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 369
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K003238.
KONICA DIRECT DIGITIZER REGIUS MODEL 350
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FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
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ADC PEDIATRIC
K012750 · Agfa Corp. · Nov 2001
XPLORER 1000
K992955 · Imaging Dynamics Corp. · Jun 2000
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
K993861 · Fujifilm Medical System U.S.A., Inc. · Feb 2000
STINGRAY DR, MODEL 1
K992794 · Infimed, Inc. · Nov 1999