Cleared Traditional

K170480 - Models 3543A, 4343A, 2929A and A843B

K170480 is an FDA 510(k) clearance for Models 3543A, manufactured by Shanghai PZ Medical Technolgoy Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K170480 · Shanghai PZ Medical Technolgoy Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
141d
Days
Class 2
Risk

K170480 is an FDA 510(k) clearance for the Models 3543A, 4343A, 2929A and A843B. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Shanghai PZ Medical Technolgoy Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 7, 2017 after a review of 141 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K170480

510(k) Number K170480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2017
Decision Date July 07, 2017
Days to Decision 141 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
34d slower than avg
Panel avg: 107d · This submission: 141d
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 Consultant

Organizeus, Inc.
Jeff Moeller

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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K170480.
Aquarius 8600 1417WC
K171175 · Imaging Dynamics Company , Ltd. · Oct 2017
CareView 1800Cw X-ray Flat Panel Detectors
K172581 · Careray Digital Medical System Co., Ltd. · Sep 2017
SKR 3000
K171716 · Konica Minolta, Inc. · Aug 2017
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
K171461 · Philips Medical Systems Dmc GmbH · Jul 2017
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
K163624 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2017
BSD4343R Digital Flat Panel X-ray Detector
K171485 · Bontech, Inc. · Jun 2017