Cleared Traditional

K875088 - XENON CT

K875088 is an FDA 510(k) clearance for XENON CT, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K875088 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jul 1988
Decision
230d
Days
Class 2
Risk

K875088 is an FDA 510(k) clearance for the XENON CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on July 26, 1988 after a review of 230 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 - K875088

510(k) Number K875088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date July 26, 1988
Days to Decision 230 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 107d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 723
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K875088.
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
K881674 · Shimadzu Precision Instruments, Inc. · Sep 1988
TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM
K882022 · Philips Medical Systems, Inc. · Aug 1988
CT MAX 640 #B7940 JA/JE
K882581 · General Electric Co. · Aug 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
K875370 · Shimadzu Precision Instruments, Inc. · May 1988
PICS-2000
K880822 · Philips Medical Systems, Inc. · Mar 1988
SOMATOM PLUS
K880965 · Siemens Medical Solutions USA, Inc. · Mar 1988