Cleared Traditional

K892342 - TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM

K892342 is an FDA 510(k) clearance for TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC..., manufactured by Bay Shore Medical Equipment Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K892342 · Bay Shore Medical Equipment Corp. · Radiology device
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Nov 1989
Decision
226d
Days
Class 2
Risk

K892342 is an FDA 510(k) clearance for the TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Bay Shore Medical Equipment Corp. (Bay Shore, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 226 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 Bay Shore Medical Equipment Corp. devices

FDA 510(k) Submission Details - K892342

510(k) Number K892342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date November 17, 1989
Days to Decision 226 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 107d · This submission: 226d
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 K892342.
ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL
K896596 · Instrumentarium Imaging, Inc. · May 1991
ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
K900989 · Fischer Imaging Corp. · Mar 1990
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC
K896609 · Philips Medical Systems North America, Inc. · Jan 1990
STEREOTACTIC BIOPSY ATTACHMENT
K884107 · Siemens Medical Solutions USA, Inc. · May 1989
MAMMOMAT C
K890784 · Siemens Medical Solutions USA, Inc. · May 1989
CYTOGUIDE
K885020 · Philips Medical Systems North America, Inc. · Apr 1989