Cleared Traditional

K101861 - TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM

K101861 is an FDA 510(k) clearance for TRUEVISION 3D VISUALIZATION AND GUIDANC..., manufactured by Truevision Systems, Incorporated. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K101861 · Truevision Systems, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
173d
Days
Class 2
Risk

K101861 is an FDA 510(k) clearance for the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Truevision Systems, Incorporated (Santa Barbara, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 173 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Truevision Systems, Incorporated devices

FDA 510(k) Submission Details - K101861

510(k) Number K101861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2010
Decision Date December 22, 2010
Days to Decision 173 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 110d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 78
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K101861.
KOWA VX-20
K112330 · Kowa Co. , Ltd. · Feb 2012
DIGITAL RETINAL CAMERA
K111612 · Canon, Inc. · Sep 2011
KOWA NONMYD WX
K101628 · Kowa Co. , Ltd. · Jan 2011
KOWAGENESIS-DF
K091098 · Kowa Co. , Ltd. · Aug 2009
KOWA VX-10 A
K091683 · Kowa Co. , Ltd. · Jul 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
K090466 · Canon, Inc. · Mar 2009