K982769 · Mitra Imaging, Inc. · LLZ · Nov 3, 1998 · Radiology
Device Facts
Record ID
K982769
Device Name
MITRA IMAGING INC. EXHIBIT
Applicant
Mitra Imaging, Inc.
Product Code
LLZ · Radiology
Decision Date
Nov 3, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
Exhibit is a software package, which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols. Images sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device. Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.
Device Story
Exhibit is a PC-based, DICOM-compliant PACS software for teleradiology. It receives DICOM images, converts them into JPEG (for thumbnails) and wavelet formats using standard protocols, and stores them in a transient local cache. Users view images via a Java applet within standard web browsers (e.g., Netscape, Internet Explorer) over hospital intranets or remote internet connections. The system runs on off-the-shelf PC hardware using TCP/IP communication. Clinicians use the software to perform basic image manipulations like window leveling, flipping, rotating, and zooming. By enabling remote access to medical images, the device facilitates timely clinical review and decision-making, benefiting patients through improved access to diagnostic information.
Clinical Evidence
No clinical data. Effectiveness was established through extensive bench testing performed by programmers, non-programmers, quality control staff, and potential customers.
Technological Characteristics
Software-only or PC-based PACS; DICOM-compliant; uses Java applet for browser-based viewing; TCP/IP communication; JPEG and wavelet image compression; runs on off-the-shelf PC hardware (Windows NT).
Indications for Use
Indicated for viewing DICOM images over hospital intranets or remote internet locations. Intended for use by clinicians as a transient viewing tool, not for long-term archiving.
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).
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K982769 P. 1 of 4
3 1998 NOV
# 510(k) SUMMARY
In accordance with the provisions of the Safe Medical Device Act of 1990, Mitra Imaging, Inc. is providing a summary of safety and effectiveness information regarding the Exhibit software.
- 1.1 Company Identification
Mitra Imaging, Inc. 115 Randall Drive Waterloo, Ontario, Canada N2V 1C5 Tel: (519) 746-2900 Fax: (519) 746-3745
- 1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116
- 1.3 Date of Submission
August 6, 1998
- 1.4 Device Name
Classification Name: Common/Usual Name: Proprietary Name:
PACS Teleradiology System Exhibit
- 1.5 Substantial Equivalence
The Exhibit software is substantially equivalent to the Algotec Systems Ltd. Product, MediSurf that is covered under K971347.
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K982769 p. 2 of 4
#### 1.6 Device Description and Intended Use
Exhibit is a software package, which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols.
lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device.
Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.
### 1.7 Software Development
Mitra certifies that the Exhibit software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used to convert DICOM images to formats that can be displayed within web browsers.
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K982769 p. 3 of 4
#### 1.8 Safety and Effectiveness
## General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and indications for use.
The hardware components specified (but not supplied) are all "off the shelf" computer components.
## Validation and Effectiveness:
Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.
## Substantial Equivalence:
The Exhibit software is a software package used to receive DICOM images, convert them to a web-browser compatible format, and to transfer those converted images to a viewing applet.
Exhibit is substantially equivalent to the Algotec MediSurf product, in that it receives DICOM images, converts them to wavelet format and displays them within a web browser. The intended use and technological characteristics of the system are virtually identical to MediSurf (K971347). Any differences between the Exhibit software and the equivalent device have no significant influence on safety or effectiveness.
It is our conclusion that there is no software component in the Exhibit product or hardware component which would be used in conjunction with the Exhibit product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "Level of Concern" of the Mitra Exhibit product is "minor".
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## 1.9 Substantial Equivalence Chart
| Specification | Exhibit (This submission) | MediSurf (K971347) |
|------------------------------------------------------|------------------------------------|-----------------------------------|
| Graphical User<br>Interface | Yes | Yes |
| | | |
| Uses Java<br>programming<br>language | Yes | Yes |
| | | |
| | | |
| Applets viewed inside<br>web browser | Yes | Yes |
| | | |
| Applets stored on<br>remote server | Yes | Yes |
| | | |
| Communications | TCP/IP | TCP/IP |
| Image Review | Window Level/Flip/Rotate/Zoom | Window Level/Flip/Rotate/Zoom/Pan |
| Server Platform | PC - Windows NT | UNIX |
| Client Platform | Any Java-compatible web<br>browser | Any Java-compatible web browser |
| JPEG for thumbnail<br>view | Yes | No |
| | | |
| Wavelet compression<br>for transmission of<br>images | Yes | Yes |
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Re:
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the top half of the circle. Inside the circle is a stylized emblem featuring three abstract human figures, represented by flowing lines, positioned closely together.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 1998
MITRA Imaging, Inc. c/o Gary J. Allesbrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578
K982769 Teleradiology System Dated: August 6, 1998 Received: August 7, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Allesbrook:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitm diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrividsmardsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin. Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K982769
Device Name: Mitra Imaging Inc., Exhibit
Indications For Use:
Exhibit is a software package, which may be marketed as a software only solution, as well as in coniunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols.
lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device.
Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 901.109)
OR
Over-the-Counter Use
Eminl C. Syzman
Division Sign Off
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982769
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.
