Cleared Special

K072984 - SATURN 9000-550

K072984 is an FDA 510(k) clearance for SATURN 9000-550, 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 22-day FDA review.

K072984 · New Medical Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2007
Decision
22d
Days
Class 2
Risk

K072984 is an FDA 510(k) clearance for the SATURN 9000-550. 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 November 14, 2007 after a review of 22 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all New Medical Co., Ltd. devices

FDA 510(k) Submission Details - K072984

510(k) Number K072984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2007
Decision Date November 14, 2007
Days to Decision 22 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
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 294
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