Cleared Traditional

K970627 - E. CAM COINCIDENCE MODE (CM)

K970627 is the FDA 510(k) clearance for E. CAM COINCIDENCE MODE (CM) by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K970627 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 1997
Decision
197d
Days
Class 2
Risk

K970627 is an FDA 510(k) clearance for the E. CAM COINCIDENCE MODE (CM). 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 September 4, 1997 after a review of 197 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K970627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1997
Decision Date September 04, 1997
Days to Decision 197 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
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 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K970627.
IMAGE FUSION AND REVIEW SYSTEM
K973233 · Adac Laboratories · Nov 1997
MCD-AC
K971980 · Adac Laboratories · Oct 1997
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · Siemens Medical Solutions USA, Inc. · Sep 1997
VANTAGE 2.1 EXSPECT
K971878 · Adac Laboratories · Aug 1997
E. CAM PROFILE ATTENUATION CORRECTION
K963983 · Siemens Corp. · Mar 1997
UHE COLLIMATOR (210591)
K963406 · Philips Medical Systems (Cleveland), Inc. · Feb 1997