Cleared Traditional

K874040 - MAMEX DC S SL10/MG14

K874040 is an FDA 510(k) clearance for MAMEX DC S SL10/MG14, manufactured by Orion Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K874040 · Orion Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
49d
Days
Class 2
Risk

K874040 is an FDA 510(k) clearance for the MAMEX DC S SL10/MG14. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on November 23, 1987 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orion Corp. devices

FDA 510(k) Submission Details - K874040

510(k) Number K874040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1987
Decision Date November 23, 1987
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K874040.
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · General Electric Co. · May 1988
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531 · Fischer Imaging Corp. · May 1988
SHIMADZU MAMMOGRAPHIC STAND MR-30
K875377 · Shimadzu Precision Instruments, Inc. · Feb 1988
ALPHA II DIAGNOSTIC X-RAY
K864958 · Ausonics Pty , Ltd. · Jan 1987
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692 · Fischer Imaging Corp. · Dec 1986
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710 · Ausonics Pty , Ltd. · Oct 1986