Cleared Traditional

K882231 - SL SERIES

K882231 is the FDA 510(k) clearance for SL SERIES by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K882231 · Philips Medical Systems, Inc. · Radiology device
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Sep 1988
Decision
118d
Days
Class 2
Risk

K882231 is an FDA 510(k) clearance for the SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on September 22, 1988 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 K882231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1988
Decision Date September 22, 1988
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 316
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K882231.
SATURNE 42 AND 43
K883019 · General Electric Co. · Nov 1988
SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25
K883264 · Philips Medical Systems, Inc. · Oct 1988
MODIFIED SL-SERIES LINEAR ACCELERATORS
K883067 · Philips Medical Systems, Inc. · Sep 1988
VARIAN CLINAC 1800S
K882326 · Varian Assoc., Inc. · Sep 1988
SL SERIES, SL 15, 18, 20 & 25
K874558 · Philips Medical Systems, Inc. · May 1988
GRATICULE
K871214 · Mick Radio-Nuclear Instruments, Inc. · May 1987