Cleared Traditional

K890100 - PENN-PET SCANNER

K890100 is an FDA 510(k) clearance for PENN-PET SCANNER, manufactured by Ugm Medical Systems, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K890100 · Ugm Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
93d
Days
Class 2
Risk

K890100 is an FDA 510(k) clearance for the PENN-PET SCANNER. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ugm Medical Systems, Inc. (Wayne, US). The FDA issued a Cleared decision on April 13, 1989 after a review of 93 days - within the typical 510(k) review window.

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 Ugm Medical Systems, Inc. devices

FDA 510(k) Submission Details - K890100

510(k) Number K890100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1989
Decision Date April 13, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
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 356
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K890100.
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
K894056 · Shimadzu Medical Systems · Nov 1989
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
SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION
K875378 · Shimadzu Precision Instruments, Inc. · Nov 1988
NON-CIRCULAR ORBITING OPTION
K861252 · Siemens Gammasonics, Inc. · Apr 1986