Cleared Traditional

K151053 - PSPIX 2 scanner

K151053 is an FDA 510(k) clearance for PSPIX 2 scanner, manufactured by Sopro - Acteon Group. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K151053 · Sopro - Acteon Group · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
102d
Days
Class 2
Risk

K151053 is an FDA 510(k) clearance for the PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size .... Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Sopro - Acteon Group (La Ciotat, FR). The FDA issued a Cleared decision on July 31, 2015 after a review of 102 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Sopro - Acteon Group devices

FDA 510(k) Submission Details - K151053

510(k) Number K151053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date July 31, 2015
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
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 - MUH System, X-ray, Extraoral Source, Digital

All 96
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K151053.
RIOScan (RPS500)
K160788 · Ray Co., Ltd. · Apr 2016
Myray- HYPERION X5
K152162 · Cefla S.C. · Dec 2015
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
K153060 · Rayence Co., Ltd. · Nov 2015
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
K151707 · Rayence Co., Ltd. · Jul 2015
Digital Dental Intra Oral Sensor, EzSensor Smart
K150797 · Rayence Co., Ltd. · May 2015
RAYSCAN A-EXPERT
K142058 · Ray Co., Ltd. · Apr 2015