IMAGEnet 6 Ophthalmic Data System— 510(k) K171370
Substantially EquivalentTopcon Corporation
FDA 510(k) clearance K171370 for IMAGEnet 6 Ophthalmic Data System, Substantially Equivalent on 2017-11-01. Applicant: Topcon Corporation. Device class: 2.
Clearance details
- Applicant
- Topcon Corporation
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code NFJ
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view all- K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
- K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
- K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
- K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
- K221111 — Non-Mydriatic Retinal Camera NW500
Recalls naming K171370
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171370.
Data sourced from openFDA. This site is unofficial and independent of the FDA.