Cleared Traditional

K071398 - SCANVIEW, MODEL SC-300 (FDA 510(k) Clearance)

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

K071398 · Applied Spectral Imaging , Ltd. · Hematology device
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Oct 2007
Decision
136d
Days
Class 2
Risk

K071398 is an FDA 510(k) clearance for the SCANVIEW, MODEL SC-300. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Applied Spectral Imaging , Ltd. (Ramat Gavriel Migdal Hahemek, IL). The FDA issued a Cleared decision on October 4, 2007 after a review of 136 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 Spectral Imaging , Ltd. devices

Submission Details

510(k) Number K071398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2007
Decision Date October 04, 2007
Days to Decision 136 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 113d · This submission: 136d
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.