Cleared Traditional

K896458 - ASPECT GAMMA CAMERA

K896458 is an FDA 510(k) clearance for ASPECT GAMMA CAMERA, manufactured by Digital Scintigraphics, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K896458 · Digital Scintigraphics, Inc. · Radiology device
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Dec 1989
Decision
39d
Days
Class 2
Risk

K896458 is an FDA 510(k) clearance for the ASPECT GAMMA CAMERA. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Digital Scintigraphics, Inc. (Cambridge, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 39 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 Digital Scintigraphics, Inc. devices

FDA 510(k) Submission Details - K896458

510(k) Number K896458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date December 22, 1989
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
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 396
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K896458.
ECAT SCANNER
K910048 · Cti Pet Systems, Inc. · May 1991
MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
K900892 · Siemens Gammasonics, Inc. · May 1990
DIACAM GAMMA CAMERA SYSTEM
K901019 · Siemens Gammasonics, Inc. · Apr 1990
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