Cleared Traditional

K913929 - DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

K913929 is an FDA 510(k) clearance for DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM, manufactured by Ophthalmic Imaging Systems. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K913929 · Ophthalmic Imaging Systems · Ophthalmic device
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Nov 1991
Decision
85d
Days
Class 2
Risk

K913929 is an FDA 510(k) clearance for the DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Ophthalmic Imaging Systems (Sacramento, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 85 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.

FDA 510(k) Submission Details - K913929

510(k) Number K913929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date November 27, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
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 153
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K913929 · DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
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