Cleared Traditional

K940236 - QUANTITATIVE HEART

K940236 is an FDA 510(k) clearance for QUANTITATIVE HEART, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K940236 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 1994
Decision
105d
Days
Class 2
Risk

K940236 is an FDA 510(k) clearance for the QUANTITATIVE HEART. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on May 3, 1994 after a review of 105 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K940236

510(k) Number K940236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1994
Decision Date May 03, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
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 365
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K940236.
PATLAK & FDG AUTORADIOGRAPHIC
K936001 · GE Medical Systems · Sep 1994
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER
K942146 · Siemens Medical Solutions USA, Inc. · Sep 1994
SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
K942116 · Siemens Corp. · Jul 1994
MAGELLAN
K940300 · GE Medical Systems · Mar 1994
ECAT PRT
K940478 · Cti Pet Systems, Inc. · Mar 1994
C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
K932745 · Adac Laboratories · Aug 1993