Cleared Traditional

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS (K954143) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954143 · Hitachi Medical Corp. of America · Radiology device
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Dec 1995
Decision
112d
Days
Class 2
Risk

K954143 is an FDA 510(k) clearance for the HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 112 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 Hitachi Medical Corp. of America devices

Submission Details

510(k) Number K954143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date December 22, 1995
Days to Decision 112 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
5d slower than avg
Panel avg: 107d · This submission: 112d
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 178
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K954143.
PRISM 3000XPV SYSTEM (210714)
K961577 · Philips Medical Systems (Cleveland), Inc. · Jul 1996
XENON OPTION TO PRISM 3000
K955484 · Philips Medical Systems (Cleveland), Inc. · Mar 1996
SPECTEF PROTOCOL
K954874 · GE Medical Systems · Feb 1996
IP500 NUCLEAR GAMMA CAMERA SYSTEM
K952109 · Siemens Medical Solutions USA, Inc. · Aug 1995
PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS
K951144 · GE Medical Systems · Jul 1995
ATTENUATION CORRECTION
K945652 · GE Medical Systems · Mar 1995