Cleared Traditional

K880352 - MTX GENERATOR

K880352 is the FDA 510(k) clearance for MTX GENERATOR by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K880352 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jul 1988
Decision
170d
Days
Class 2
Risk

K880352 is an FDA 510(k) clearance for the MTX GENERATOR. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on July 14, 1988 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 (Cleveland), Inc. devices

Submission Details

510(k) Number K880352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date July 14, 1988
Days to Decision 170 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
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K880352.
FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK
K921112 · Fujifilm Medical System U.S.A., Inc. · Apr 1993
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · Hologic, Inc. · Oct 1991
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · Medrad, Inc. · Nov 1988
BC 1400 HAND POSITIONER
K872316 · Instrumentation Industries, Inc. · Aug 1987
BC 1800 FINGER POSITIONER
K872317 · Instrumentation Industries, Inc. · Aug 1987
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · General Electric Co. · Jun 1987