Cleared Traditional

K062755 - IKONISCOPE ONCOFISH BLADDER TEST SYSTEM

K062755 is an FDA 510(k) clearance for IKONISCOPE ONCOFISH BLADDER TEST SYSTEM, manufactured by Ikonisys, Inc.. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K062755 · Ikonisys, Inc. · Hematology device
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Jan 2007
Decision
112d
Days
Class 2
Risk

K062755 is an FDA 510(k) clearance for the IKONISCOPE ONCOFISH BLADDER TEST SYSTEM. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Ikonisys, Inc. (New Haven, US). The FDA issued a Cleared decision on January 4, 2007 after a review of 112 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 Ikonisys, Inc. devices

FDA 510(k) Submission Details - K062755

510(k) Number K062755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2006
Decision Date January 04, 2007
Days to Decision 112 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
1d faster than avg
Panel avg: 113d · This submission: 112d
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 25
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K062755.
EASYCELL CELL LOCATOR
K092116 · Medica Corp. · May 2010
SCANVIEW, MODEL SC-300
K071398 · Applied Spectral Imaging , Ltd. · Oct 2007
DUET SYSTEM
K061602 · Bioview , Ltd. · Jan 2007
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
K061392 · Ikonisys, Inc. · Aug 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
K052577 · Ikonisys, Inc. · Jan 2006
MODIFICATION TO DUET SYSTEM
K050840 · Bioview , Ltd. · Aug 2005