Cleared Traditional

K073056 - DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9

K073056 is an FDA 510(k) clearance for DIGITAL RADIOGRAPHY SYSTEM, manufactured by Vieworks Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K073056 · Vieworks Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
14d
Days
Class 2
Risk

K073056 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Vieworks Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on November 13, 2007 after a review of 14 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 Vieworks Co., Ltd. devices

FDA 510(k) Submission Details - K073056

510(k) Number K073056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2007
Decision Date November 13, 2007
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
MORTEN S CHRISTENSEN

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 422
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K073056.
DRAD-3000E, RADREX-I
K073165 · Toshiba America Medical Systems, In.C · Nov 2007
SATURN 9000-550
K072984 · New Medical Co., Ltd. · Nov 2007
SATURN 9000-750
K072983 · New Medical Co., Ltd. · Nov 2007
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
K071682 · Alara, Inc. · Aug 2007
SATURN 9000
K063710 · New Medical Co., Ltd. · Jul 2007
DIRECT DIGITIZER, REGIUS MODEL 110
K071181 · Konica Minolta Medical & Graphic, Inc. · May 2007