Cleared Traditional

K971671 - HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)

K971671 is an FDA 510(k) clearance for HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (H..., manufactured by Heidelberg Engineering. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K971671 · Heidelberg Engineering · Ophthalmic device
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Jul 1997
Decision
83d
Days
Class 2
Risk

K971671 is an FDA 510(k) clearance for the HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C). Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Heidelberg Engineering (Heidelberg, DE). The FDA issued a Cleared decision on July 29, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Heidelberg Engineering devices

FDA 510(k) Submission Details - K971671

510(k) Number K971671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1997
Decision Date July 29, 1997
Days to Decision 83 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
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLI Ophthalmoscope, Ac-powered

All 54
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