Cleared Traditional

K143257 - KrystalRad 11000 and KrystalRad 3000 Di...

K143257 is an FDA 510(k) clearance for KrystalRad 11000 and KrystalRad 3000 Di..., manufactured by Medicatech USA. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K143257 · Medicatech USA · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
85d
Days
Class 2
Risk

K143257 is an FDA 510(k) clearance for the KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Medicatech USA (Irvine, US). The FDA issued a Cleared decision on February 6, 2015 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medicatech USA devices

FDA 510(k) Submission Details - K143257

510(k) Number K143257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2014
Decision Date February 06, 2015
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
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 - KPR System, X-ray, Stationary

All 190
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K143257.
GF50A
K151419 · Samsung Electronics Co., Ltd. · Jun 2015
GC85A
K150165 · Samsung Electronics Co., Ltd. · Apr 2015
DRX-EVOLUTION
K141837 · Carestream Health, Inc. · Mar 2015
Digital Diagnostic X-ray System (GC80)
K143029 · Samsung Electronics Co., Ltd. · Feb 2015
MULTIX FUSION VA30 & VA40
K142049 · Siemens Medical Solutions USA, Inc. · Dec 2014
XGEO GF50
K140326 · Samsung Electronics Co., Ltd. · May 2014