Cleared Traditional

K921896 - TILTING MAG

K921896 is an FDA 510(k) clearance for TILTING MAG, manufactured by Continental X-Ray Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K921896 · Continental X-Ray Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
103d
Days
Class 2
Risk

K921896 is an FDA 510(k) clearance for the TILTING MAG. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on August 3, 1992 after a review of 103 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K921896

510(k) Number K921896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1992
Decision Date August 03, 1992
Days to Decision 103 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
4d faster than avg
Panel avg: 107d · This submission: 103d
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 45
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K921896.
PATIENT INFORMATION MANAGER (PIM)
K921986 · Continental X-Ray Corp. · Oct 1992
MOBILE ATHENA HF
K922454 · Fischer Imaging Corp. · Sep 1992
MAMMOSCAN
K923061 · Fischer Imaging Corp. · Sep 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · Elscint, Inc. · Feb 1992
SENOGRAPHE DMR/SMR/DM
K913418 · General Electric Co. · Jan 1992
PHILIPS MAMMODIAGNOST BC
K913845 · Philips Medical Systems, Inc. · Dec 1991