Cleared Traditional

PIXX 1717 (K180976) - FDA 510(k) Clearance

Also marketed or referenced as:
PIXX 1417 PIXX 1212 Digital Diagnostic X-ray Receptor Panels

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180976 · Pixxgen Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
41d
Days
Class 2
Risk

K180976 is an FDA 510(k) clearance for the PIXX 1717. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Pixxgen Corporation (Anyang-Si, KR). The FDA issued a Cleared decision on May 24, 2018 after a review of 41 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 Pixxgen Corporation devices

Submission Details

510(k) Number K180976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2018
Decision Date May 24, 2018
Days to Decision 41 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
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Kamm & Associates
Daniel Kamm

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 146
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K180976.
Eclipse II
K180809 · Carestream Health, Inc. · Jun 2018
PEDRA-17F Digital Flat Panel X-ray Detector
K180989 · Radisen, Inc. · Jun 2018
17HK700G-W
K180332 · Lg Electronics · Jun 2018
VIVIX-S 1717V
K181003 · Vieworks Co., Ltd. · May 2018
SmartGrid
K180667 · Carestream Health, Inc. · Apr 2018
RADREX-I, SW V4.00 MODEL DRAD-3000E
K122842 · Toshiba America Medical Systems, In.C · Oct 2012