Cleared Traditional

K980375 - WINSCAN AUTOMATED IMAGING SYSTEM

K980375 is an FDA 510(k) clearance for WINSCAN AUTOMATED IMAGING SYSTEM, manufactured by Applied Imaging Corp.. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K980375 · Applied Imaging Corp. · Hematology device
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Jun 1998
Decision
130d
Days
Class 2
Risk

K980375 is an FDA 510(k) clearance for the WINSCAN AUTOMATED IMAGING SYSTEM. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Applied Imaging Corp. (Santa Clara, US). The FDA issued a Cleared decision on June 9, 1998 after a review of 130 days - within the typical 510(k) review window.

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 Applied Imaging Corp. devices

FDA 510(k) Submission Details - K980375

510(k) Number K980375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1998
Decision Date June 09, 1998
Days to Decision 130 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 113d · This submission: 130d
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 20
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K980375.
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188 · Chroma Vision Medical Systems, Inc. · Jul 1999
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786 · Accumed Intl., Inc. · Oct 1998
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301 · Triangle Biomedical Sciences, Inc. · Aug 1998
MICRO21 WITH WBC ESTIMATE
K973050 · Triangle Biomedical Sciences, Inc. · Nov 1997
MICRO21 WITH CEREBROSPINAL FLUID
K971470 · Triangle Biomedical Sciences, Inc. · Sep 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · Accumed Intl., Inc. · Aug 1997