510(k) Report

510(k) · Cleared

Cleared

Imagenet 5 PC Software System

K132438510(k) TraditionalCleared Oct 17, 201373-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Topcon Medical Systems, Inc. · NFJ System, Image Management, Ophthalmic

Cleared on Oct 17, 2013 after a 73-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Oct 17, 2013
Review
73 days
Class
Class II
Product code
NFJ
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2018: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant cleared2010201520202025
  1. This deviceK132438 Imagenet 5 PC Software SystemTopcon Medical Systems, Inc. · 2013
  2. Descendant · cites it directly · 3 of its ownK171370 IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK232828 IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 2024 · Recalled
  4. Descendant · cites it directly · 2 of its ownK173689 Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group · 2018
  5. Descendant · 3 generations on · 1 of its ownK241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6…Topcon Corporation · 2024
  6. Descendant · 4 generations on · 0 of its ownK253893 Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 12020: 12024: 22026: 1
2017high 2 (2024) · low 0 (2021)2026

Most influential descendants

Showing 5 of 7 · See all
  • K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · cites it directly3descendants
  • K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 2024 · 2 generations on2descendants
  • K173689Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group · 2018 · cites it directly2descendants
  • K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation · 2024 · 3 generations on1descendant
  • K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K132438Imagenet 5 PC Software SystemTopcon Medical Systems, Inc.2013—
+1K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation20171
+2K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation20241
+1K173689Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group2018—
+3K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6…Topcon Corporation2024—
+4K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201910
202010
202420
202610
FIG. 1 — Lineage of K132438, 2013–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NFJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NFJ device

  1. #1 K260694 Zeiss Clinic 360score 15.0 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation20173
K173689Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group20182

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K171370 (Topcon Corporation, 2017) has gone furthest, with 3 descendants of its own.

How does its category compare?

All NFJ devices

NFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NFJ

2in 2024

2007: 12008: 12009: 42011: 22012: 22013: 52014: 22015: 32017: 52018: 72019: 22020: 52021: 22022: 32023: 42024: 22026 (partial year): 2
2007high 7 (2018) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFJ

85in 2023

2009: 67 days median2013: 73 days median2015: 87 days median2017: 175 days median2018: 84 days median2020: 116 days median2022: 284 days median2023: 85 days median
2007high 284 (2022) · low 67 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NFJ

1in 2024

2010: 22015: 12020: 22022: 12024: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NFJ

2in 2022

2013: 62014: 12015: 22016: 292017: 42019: 22021: 12022: 2
2007high 29 (2016) · low 0 (2007)2025

MAUDE reports naming product code NFJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
200946700
20100—20
20112—00
20122—00
201357306
20142—01
201538712
20160—029
2017517504
201878400
20192—02
2020511620
20212—01
2022328412
202348500
20242—10
20250—00
20262—0—

What is it indicated for?

The IMAGEnet 5 PC Software System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon imaging devices through a direct connection with Topcon instruments or through computerized networks.

Indications for use as stated in the FDA 510(k) statement.

More from Topcon Medical Systems, Inc.

11 FDA decisions under this applicant name. See the company

  • K182376HarmonyTopcon Medical Systems, Inc. · 2018
  • K151952Synergy ODMTopcon Medical Systems, Inc. · 2015
  • K132667Synergy OdmTopcon Medical Systems, Inc. · 2013
  • K123101TRC-50DX Retinal CameraTopcon Medical Systems, Inc. · 2013
  • K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013

Recent decisions in NFJ

The NFJ category page

  • K260694Zeiss Clinic 360Carl Zeiss Meditec, AG · 2026
  • K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
  • K234076iCare ALTIUS CWCentervue S.P.A. · 2024
  • K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation · 20241 recall
  • K232944CALLISTO eyeCarl Zeiss Meditec, AG · 2023

https://510kreport.com/device/K132438 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132438: Imagenet 5 PC Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132438

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026