Cleared Traditional

K955411 - DELTA 16

K955411 is an FDA 510(k) clearance for DELTA 16, manufactured by Instrumentarium Imaging, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K955411 · Instrumentarium Imaging, Inc. · Radiology device
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Mar 1996
Decision
115d
Days
Class 2
Risk

K955411 is an FDA 510(k) clearance for the DELTA 16. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Instrumentarium Imaging, Inc. (Tuusula, Finland, FI). The FDA issued a Cleared decision on March 21, 1996 after a review of 115 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 Instrumentarium Imaging, Inc. devices

FDA 510(k) Submission Details - K955411

510(k) Number K955411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1995
Decision Date March 21, 1996
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
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 60
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K955411.
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · Bennett X-Ray Corp. · Jan 1997
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
K960381 · Elscint, Inc. · Apr 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996
REAL TIME STEREOTIX
K941191 · GE Medical Systems · May 1995
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
K944978 · Bennett X-Ray Corp. · May 1995