Cleared Traditional

SATURN 8000-GS (K110210) - FDA 510(k) Clearance

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

K110210 · New Medical Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
85d
Days
Class 2
Risk

K110210 is an FDA 510(k) clearance for the SATURN 8000-GS. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by New Medical Co., Ltd. (Walnut, US). The FDA issued a Cleared decision on April 20, 2011 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 New Medical Co., Ltd. devices

Submission Details

510(k) Number K110210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2011
Decision Date April 20, 2011
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.

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

All 141
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K110210.
PIXX 1717
K180976 · Pixxgen Corporation · May 2018
VIVIX-S 1717V
K181003 · Vieworks Co., Ltd. · May 2018
SmartGrid
K180667 · Carestream Health, Inc. · Apr 2018
AXIOM ARISTOS FX PLUS
K061054 · Siemens Medical Solutions USA, Inc. · May 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137 · Eastman Kodak Company · Mar 2006
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · Eastman Kodak Company · Jun 2005