Cleared Traditional

K882022 - TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM

K882022 is the FDA 510(k) clearance for TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K882022 · Philips Medical Systems, Inc. · Radiology device
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Aug 1988
Decision
94d
Days
Class 2
Risk

K882022 is an FDA 510(k) clearance for the TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on August 15, 1988 after a review of 94 days - within the typical 510(k) review window.

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 Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K882022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1988
Decision Date August 15, 1988
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K882022.
EXEL 2002 & 2002FS CT SCANNER
K884669 · Elscint, Inc. · Dec 1988
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
K881305 · Toshiba Medical Systems · Oct 1988
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · Philips Medical Systems (Cleveland), Inc. · Oct 1988
CT MAX 640 #B7940 JA/JE
K882581 · General Electric Co. · Aug 1988
XENON CT
K875088 · Siemens Medical Solutions USA, Inc. · Jul 1988
PICS-2000
K880822 · Philips Medical Systems, Inc. · Mar 1988