Cleared Traditional

K894056 - POSITRON EMISSION COMPUTED TOMOGRAPH SE...

K894056 is the FDA 510(k) clearance for POSITRON EMISSION COMPUTED TOMOGRAPH SE... by Shimadzu Medical Systems. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K894056 · Shimadzu Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
161d
Days
Class 2
Risk

K894056 is an FDA 510(k) clearance for the POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on November 15, 1989 after a review of 161 days - an extended review 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: 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 Shimadzu Medical Systems devices

Submission Details

510(k) Number K894056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date November 15, 1989
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 107d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 247
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K894056.
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM
K911078 · Siemens Gammasonics, Inc. · Jun 1991
MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
K900892 · Siemens Gammasonics, Inc. · May 1990
DIACAM GAMMA CAMERA SYSTEM
K901019 · Siemens Gammasonics, Inc. · Apr 1990
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
K892358 · Adac Laboratories · Aug 1989
NEUROFOCAL COLLIMATOR
K891266 · Siemens Gammasonics, Inc. · Apr 1989
ADAC VIEWPOINT (ADDITIONAL SOFTWARE)
K884349 · Adac Laboratories · Dec 1988