Cleared Traditional

K063191 - HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT

K063191 is an FDA 510(k) clearance for HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL ..., manufactured by Heidelberg Engineering. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K063191 · Heidelberg Engineering · Ophthalmic device
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Oct 2006
Decision
11d
Days
Class 2
Risk

K063191 is an FDA 510(k) clearance for the HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Heidelberg Engineering (Heidelberg, DE). The FDA issued a Cleared decision on October 31, 2006 after a review of 11 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.

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FDA 510(k) Submission Details - K063191

510(k) Number K063191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2006
Decision Date October 31, 2006
Days to Decision 11 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 110d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

OBO Device Classification - Class 2, Special Controls

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
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.