Cleared Traditional

IMS-200 (K925670) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 34
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