Cleared Traditional

K884345 - MODEL ESP-200 MAMMOGRAPHIC SYSTEM

K884345 is an FDA 510(k) clearance for MODEL ESP-200 MAMMOGRAPHIC SYSTEM, manufactured by Acoma Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K884345 · Acoma Medical Imaging, Inc. · Radiology device
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Mar 1989
Decision
160d
Days
Class 2
Risk

K884345 is an FDA 510(k) clearance for the MODEL ESP-200 MAMMOGRAPHIC SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on March 23, 1989 after a review of 160 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 Acoma Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K884345

510(k) Number K884345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date March 23, 1989
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 107d · This submission: 160d
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 88
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K884345.
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
MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150
K885135 · Bennett X-Ray Corp. · Mar 1989
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676 · Elscint, Inc. · Jan 1989
MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884677 · Elscint, Inc. · Jan 1989