Cleared Traditional

PHILIPS MAMMODIAGNOST BC (K913845) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913845 · Philips Medical Systems, Inc. · Radiology device
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Dec 1991
Decision
114d
Days
Class 2
Risk

K913845 is an FDA 510(k) clearance for the PHILIPS MAMMODIAGNOST BC. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on December 20, 1991 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 K913845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1991
Decision Date December 20, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 18
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K913845.
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · Cook, Inc. · Sep 1993
SENOGRAPHE DMR/SMR/DM
K913418 · General Electric Co. · Jan 1992
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
K914328 · Siemens Medical Solutions USA, Inc. · Dec 1991
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · Siemens Medical Solutions USA, Inc. · May 1989
MAMMOMAT C
K890784 · Siemens Medical Solutions USA, Inc. · May 1989