Cleared Traditional

K973950 - RETINAL CUBE

K973950 is an FDA 510(k) clearance for RETINAL CUBE, manufactured by Applied Spectral Imaging , Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K973950 · Applied Spectral Imaging , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
57d
Days
Class 2
Risk

K973950 is an FDA 510(k) clearance for the RETINAL CUBE. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Applied Spectral Imaging , Ltd. (Migdal Ha'Emek, IL). The FDA issued a Cleared decision on December 12, 1997 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Spectral Imaging , Ltd. devices

FDA 510(k) Submission Details - K973950

510(k) Number K973950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1997
Decision Date December 12, 1997
Days to Decision 57 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
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 104
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K973950.
OPHTHAVISION IMAGING SYSTEM
K980295 · Mrp Group, Inc. · May 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246 · Canon USA, Inc. · May 1998
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
K980357 · Konan, Inc. · Apr 1998
NIDEK HANDY
K973218 · Nidek, Inc. · Nov 1997
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K973533 · Nidek, Inc. · Nov 1997
CATARACTSCREENER CT - S
K972440 · Neitz Instruments Company, Ltd. · Sep 1997