Cleared Special

K080589 - SATURN 9000-810

K080589 is an FDA 510(k) clearance for SATURN 9000-810, manufactured by New Medical Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 100-day FDA review.

K080589 · New Medical Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
100d
Days
Class 2
Risk

K080589 is an FDA 510(k) clearance for the SATURN 9000-810. 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 June 11, 2008 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080589

510(k) Number K080589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date June 11, 2008
Days to Decision 100 days
Submission Type Special
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
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 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 K080589.
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963 · Agfa Healthcare Corporation · Jul 2008
DIGITAL RADIOGRAPHY CXDI-60G
K081648 · Canon, Inc. · Jun 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624 · Toshiba America Medical Systems, In.C · Jun 2008
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
K073670 · Orex Computed Radiography, Ltd. · Jan 2008
FLAATZ 750
K080064 · Drtech Corp. · Jan 2008
DRAD-3000E, RADREX-I
K073165 · Toshiba America Medical Systems, In.C · Nov 2007
K080589 · SATURN 9000-810
Download PDF FDA Summary New Medical Co., Ltd.