IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
Applicant
Topcon Corp.
Product Code
NFJ · Radiology
Decision Date
Sep 30, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
Indications for Use
The IMAGEnet Professional PC Software System is a software program that is intended for use in the collection, storage and management of digital images, paticant data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computcrized networks. The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slintor ms.
Device Story
IMAGEnet Professional PC Software System is a PC-based software platform for ophthalmic imaging. It interfaces with retinal cameras, non-mydriatic retinal cameras, and slit lamps to capture, archive, and manage digital images and patient diagnostic data. The system operates on Windows 2000/XP environments. It provides tools for image processing, such as stitching images together or estimating laser treatment sizes for photodynamic therapy (PDT). Used in clinical settings by eye care professionals, the software facilitates data management via direct instrument connection or computerized networks. By centralizing diagnostic information, it assists clinicians in reviewing patient history and planning treatments, potentially improving diagnostic efficiency and patient care outcomes.
Clinical Evidence
Bench testing only. Software validation testing and image capture testing were performed to verify system functionality. Results demonstrated sufficient agreement with captured images and confirmed that the software performs as intended without raising safety or effectiveness issues.
Technological Characteristics
PC-based software system; Windows 2000/XP compatible. Functions include image capture, database archival, and image processing. Connectivity via direct instrument connection or computerized networks. No specific hardware materials or energy sources defined as it is a software-only system.
Indications for Use
Indicated for use with retinal camera or digital camera imaging devices (including retinal cameras, non-mydriatic retinal cameras, and slit lamps) to collect, store, and manage digital images, patient data, and clinical information for eye care.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
IMAGEnet Digital Ophthalmic Imaging System (v.2.12; IMAGEnet 2000) (K870039)
Nidek Advanced Vision Information System (NAVIS) (K013694)
Submission Summary (Full Text)
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# SEP 3 0 2008
210(K)
#### Page 16 of 98
1 (
# 5. 510(k) Summary as required by 21 CFR 807.92(c)
510(k) Owner:
Topcon Corporation. 75-1 Hasunuma-cho, Itabashi-ku Tokyo, Japan 174
U.S. Facility: Topcon Medical Systems, Inc. 37 West Century Road Paramus, New Jersey 07652 Telephone: (201) 599-5153 Facsimile: (201) 599-5240
Contact person:
Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 Phone: (513) 961-8200 Facsimile: (513) 961-2858
Date: April 28, 2008
IMAGEnet Professional PC Software System Trade Name:
Digital Image Management Software Common names: Digital Imaging Software for Retinal Cameras Digital Imaging Software for Slit Lamps
Classification Name: Picture archiving and communications system 21 CFR 892.2050
Product Code: NFJ
Identification of a Legally Marketed Predicate Device
The IMAGEnet Professional PC Software System is substantially equivalent to the IMAGEnet Digital Ophthalmic Imaging System (v.2.12; IMAGEnet 2000) marketed by Topcon, 510(k) Premarket Notification Number K870039, FDA Product Code DSF Secondly, it is substantially equivalent to the Nider Rolly Courted Vision Information System (NAVIS) marketed by Nidek Inc., 510(k) Premarket Notification Number: K013694, FDA Product Code NFJ.
General Description
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Page 17 of 98
### 510(K)
The IMAGEnet Professional PC Software System is a computerized software system that The INAOLIC: Professional - images of the retina and anterior segment of the eye. The collects, stores, and manificante sincessor with retinal camera or digital IMAGEIEL Protessional I O betware Byoten in Cameras, non-mydriatic retinal cameras, and slit
camera imaging devices, including retinal cameras, non-mydriatio retinal cameras, camera iniaging dovroob, metaling reasing reached in a Windows 2000 or lamps. The MACLife. I rolossional PC Borthale of image capture, database archival of images, Windows XF Companiele I C to laomate the finitered. On the suptional functions that and image processing. The thirle interestigal images together or estimate the desired laser treatment size for photodynamic therapy (PDT). The Topcon IMAGEnet Professional PC Software System is intended as a software program for the use in the management of digital images acquired from diagnostic instruments that capture images of the retina and anterior segment of the eye.
#### Intended Use
The IMAGEnet Professional PC Software System is a software program that is intended for r no mir reallection, storage and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computerized networks.
#### Performance Data
Software validation testing and image capture testing were performed on the IMAGEnet Professional PC Software System. Test results for the IMAGEnet Professional Software Frorem demonstrated sufficient agreement with captured images. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.
#### Basis of Substantial Equivalence
The IMAGEnet Professional PC Software System is substantially equivalent to the IMAGEnet Digital Ophthalmic Imaging System (v.2.12 IMAGEnet 2000) marketed by Topcon, 510(k) Premarket Notification Number K870039, FDA Product Code DSF, and regulation 21CFR \$870.2810 (Recorder, paper chart) in software design and specifications, intended use, and compatible digital diagnostic equipment. Secondly, it is also substantially equivalent to the Nidek Advanced Vision Information System (NAVIS) marketed by Nidek Inc., 510(k) Premarket Notification Number: K013694, FDA Product Code NFJ, and regulation 21CFR \$892.2050 (picture archiving and communications system) in basic design concept, in intended use, and use with similar digital diagnostic equipment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird.
SEP 3 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Topcon Corporation c/o Tamas Borsai, TUV Rheinland of North America 12 Commerce Road Newton, CT 06470
Re: K082364
Trade/Device Name: IMAGEnet Professional PC Software System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: September 15th, 2008 Received: September 18th, 2008
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
M. B. Egerston, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear、Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 15 of 98
# 510(K)
# 4. Indications for Use Statement
K082364 510(k) Number (if known):
Device Name: IMAGEnet Professional PC Software System
## Indications for Use:
The IMAGEnet Professional PC Software System is a software program that is intended for use in the collection, storage and management of digital images, paticant data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computcrized networks.
The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slintor ms.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
Ba
(Division Sign-Off)
**610(k) Number** k 082364
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
