Cleared Traditional

K063710 - SATURN 9000 (FDA 510(k) Clearance)

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

K063710 · New Medical Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
214d
Days
Class 2
Risk

K063710 is an FDA 510(k) clearance for the SATURN 9000. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by New Medical Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on July 16, 2007 after a review of 214 days - an extended review 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: 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 New Medical Co., Ltd. devices

Submission Details

510(k) Number K063710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2006
Decision Date July 16, 2007
Days to Decision 214 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
107d slower than avg
Panel avg: 107d · This submission: 214d
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 420
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K063710.
Lux HD 2530 detector (Lux HD 2530)
K252911 · Iray Imaging Technology (Haining) Limited · Oct 2025
Yushan X-Ray Flat Panel Detector
K250211 · Innocare Optoelectronics Corp. · Jul 2025
SKR 3000
K250665 · Konica Minolta, Inc. · Jun 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · Allengers Medical Systems Limited · Apr 2025
EXPD 114
K242770 · DRTECH Corporation · Mar 2025
EXPD 4343N1
K243443 · DRTECH Corporation · Mar 2025