Cleared Traditional

K920470 - MEYER FOREIGN BODY LOCATOR

K920470 is an FDA 510(k) clearance for MEYER FOREIGN BODY LOCATOR, manufactured by Seymour W. Meyer. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K920470 · Seymour W. Meyer · Radiology device
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Aug 1992
Decision
211d
Days
Class 2
Risk

K920470 is an FDA 510(k) clearance for the MEYER FOREIGN BODY LOCATOR. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Seymour W. Meyer (Great Neck, US). The FDA issued a Cleared decision on August 26, 1992 after a review of 211 days - an extended review 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: 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 Seymour W. Meyer devices

FDA 510(k) Submission Details - K920470

510(k) Number K920470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1992
Decision Date August 26, 1992
Days to Decision 211 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 107d · This submission: 211d
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 111
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K920470.
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
TILTING MAG
K921896 · Continental X-Ray Corp. · Aug 1992
CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO
K915201 · Bennett X-Ray Corp. · Jul 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · Elscint, Inc. · Feb 1992