Cleared Traditional

K925670 - IMS-200

K925670 is an FDA 510(k) clearance for IMS-200, manufactured by Intelligent Medica Imaging, Inc.. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K925670 · Intelligent Medica Imaging, Inc. · Hematology device
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Jul 1993
Decision
255d
Days
Class 2
Risk

K925670 is an FDA 510(k) clearance for the IMS-200. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Intelligent Medica Imaging, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on July 23, 1993 after a review of 255 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intelligent Medica Imaging, Inc. devices

FDA 510(k) Submission Details - K925670

510(k) Number K925670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date July 23, 1993
Days to Decision 255 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 113d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOY Device Classification - Class 2, Special Controls

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
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 Hematology devices follow this clearance model.

Regulatory Peers - JOY Device, Automated Cell-locating

All 27
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K925670.
MDX 2000, DIGITAL ANALYZER
K970824 · Shotwell & Carr, Inc. · May 1997
MICRO21 WITH ANA
K960774 · Triangle Biomedical Sciences, Inc. · May 1996
MICRO21 WITH RETIC
K960776 · Triangle Biomedical Sciences, Inc. · May 1996
RE-CELL SLIDE RECAP
K772139 · Geometric Data, Div. Smithkline Corp. · Jan 1978
SCANNING SYS., AUTO. COMP., ACS1000
K772140 · Honeywell, Inc. · Dec 1977