Cleared Traditional

K874558 - SL SERIES, SL 15, 18, 20 & 25

K874558 is an FDA 510(k) clearance for SL SERIES, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K874558 · Philips Medical Systems, Inc. · Radiology device
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May 1988
Decision
180d
Days
Class 2
Risk

K874558 is an FDA 510(k) clearance for the SL SERIES, SL 15, 18, 20 & 25. 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 May 2, 1988 after a review of 180 days - an extended review cycle.

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

FDA 510(k) Submission Details - K874558

510(k) Number K874558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1987
Decision Date May 02, 1988
Days to Decision 180 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
73d slower than avg
Panel avg: 107d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

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 551
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K874558.
MODIFIED SL-SERIES LINEAR ACCELERATORS
K883067 · Philips Medical Systems, Inc. · Sep 1988
SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
K882231 · Philips Medical Systems, Inc. · Sep 1988
VARIAN CLINAC 1800S
K882326 · Varian Assoc., Inc. · Sep 1988
GRATICULE
K871214 · Mick Radio-Nuclear Instruments, Inc. · May 1987
COMPUTER CONTROLLED EXTENSION (CCX)
K863705 · Varian Assoc., Inc. · Jan 1987
CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C)
K862645 · Varian Assoc., Inc. · Oct 1986