Cleared Traditional

K090178 - ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8

K090178 is an FDA 510(k) clearance for ATTRIUS, manufactured by Neusoft Positron Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K090178 · Neusoft Positron Medical Systems Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
88d
Days
Class 2
Risk

K090178 is an FDA 510(k) clearance for the ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NS.... Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Neusoft Positron Medical Systems Co., Ltd. (Shenyang, Liaoning, CN). The FDA issued a Cleared decision on April 24, 2009 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 Neusoft Positron Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K090178

510(k) Number K090178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2009
Decision Date April 24, 2009
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 321
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K090178.
DISCOVERY NM 630
K111445 · Ge Healthcare · Jun 2011
BIOGRAPH MCT FAMILY
K101550 · Siemens Medical Solutions USA, Inc. · Sep 2010
DISCOVERY MODEL NM/CT 670
K093514 · Ge Medical Systems F.I. Haifa · Dec 2009
AUTOSPECT
K090403 · Philips Medical Systems (Cleveland), Inc. · Mar 2009
BIOGRAPH 16 TRUE POINT SYSTEMS
K083852 · Siemens Medical Solutions USA, Inc. · Mar 2009
CARDIUS 3 X-ACT
K083649 · Digirad Corp. · Mar 2009