Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine procedure. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
Device Story
Pegasys Ultra is a UNIX-based SUN workstation and processing console for nuclear medicine. It receives image data from nuclear medicine gamma cameras; allows operators to process, enhance, and reconstruct data sets; and produces quantitative data from regions of interest. The system features a graphical user interface with icons and menus for applications like Renal Analysis. Operators display images, curves, and text in various color maps, intensities, and zoom factors. The device aids nuclear physicians in determining diagnoses by providing processed images and quantitative analysis. It is intended for use in clinical settings by trained healthcare professionals. The system includes a remote service package (TeleLOGIC).
Clinical Evidence
Bench testing only. Verification and validation testing were performed in compliance with ADAC Laboratories procedures to demonstrate that the device met all specifications and performed equivalently to the predicate device.
Technological Characteristics
UNIX-based SUN workstation; high-resolution graphics display console; software-based image processing applications; menu-driven user interface; supports multi-viewport display; remote service connectivity via TeleLOGIC.
Indications for Use
Indicated for use by nuclear physicians as a tool to process, analyze, and display nuclear medicine images/data for the diagnosis of disease conditions in various organs, tissues, and anatomical structures. Operated by qualified healthcare professionals trained in nuclear medicine equipment.
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
PEGASYS Nuclear Medicine Imaging Computer (K892358)
Submission Summary (Full Text)
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# 510(k) SUMMARY
K993946
| Submitter name: | ADAC Laboratories, Inc. |
|------------------------|---------------------------------------|
| Submitter Address: | 540 Alder Drive<br>Milpitas, CA 95035 |
| Submitter Telephone: | (408) 468-3766 |
| Submitter Fax: | (408) 468-3050 |
| Contact Person: | Janice Brown |
| Date Summary Prepared: | February 23, 2000 |
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## 510(k) SUMMARY
| Device trade name: | PEGASYS Ultra |
|----------------------|-----------------------------------------------------------------------------|
| Common name: | Nuclear Medicine Imaging Workstation |
| Classification name: | Picture Archiving and Communications System<br>(per 21CFR section 892.2050) |
| Predicate Devices: | PEGASYS Nuclear Medicine Imaging Computer, K892358 |
#### Device Description:
Pegasys Ultra is a UNIX-based SUN display workstation and central processor, a high resolution processing console and TeleLOGIC remote service package. It provides for operator interaction with comprehensive ADAC PEGASYS clinical software provided by ADAC Laboratories and includes On-Line User Documentation.
The workstation allows a qualified operator to process and enhance the data, reconstruct data sets, produce quantitative data from regions of interest, display images, curves and text. Images can be displayed in color, show fluorescence intensity, and different zoom factors. Identification parameters include volume, size, and shape. Use of multiple viewports allows the operator to display images with different color maps, intensities, and zoom factors simultaneously. The PEGASYS desktop contains graphic icons allowing selection of an application such as Renal Analysis, and a menu selection, which consists of a main menu and submenus for image processing of the multiple applications.
#### Intended Use:
Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine procedure. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
#### Summary of Technological Characteristics Compared to Predicate Devices:
The predicate device is the "PEGASYS" Nuclear Medicine Imaging Computer, Class II, K892358/A. The FDA determined "PEGASYS" (K892358/A) was substantially equivalent to devices marketed prior to May 28, 1976, the enactment date of the Medical Device Amendments. Both the PEGASYS "Ultra" and the "PEGASYS" Nuclear Medicine Imaging Computer are workstations with SUN UNIX based computers, high resolution graphics and image display consoles for use with ADAC software image processing applications. Both devices use menus and allow the qualified operator to define regions of interest. The PEGASYS "Ultra" software and hardware is more sophisticated, and has progressed with the field of computers and nuclear medicine, but,
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the basic algorithms and original calculations have not changed. The functions have been built into the monoliths and protocols in use today, and in conjunction with the upgraded hardware have added speed and an enhanced user interface for the processing of nuclear images, which aid the physician towards a suggestive diagnosis. Additionally, the acquisition software portion has been removed to a separate computer system and is no longer a part of the base Pegasys software.
#### Summary of Testing
Non-clinical testing was performed for Verification and Validation testing. Testing were completed in compliance with ADAC Laboratories procedures to demonstrate that the Pegasys "Ultra" has met all its specifications, demonstrating substantially equivalent performance to its predicate device, and is safe and effective for its intended use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
19 2000 MAR
Janice E. Brown, RAC Corporate Director, Regulatory Affairs ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
Re:
K993946 Pegasys Ultra Dated: February 23, 2000 Received: February 25, 2000 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Ms. Brown:
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 inclusions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Aproval), 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 Requirition (QS) 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 notfication submission you micht have under sections 531 through 542 of the Act for devices under 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 predication 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 requilation entitled. "Misbranding by reference to premarket notification" (21CFR 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510 (k) NUMBER (IF KNOWN) : __ K993946
DEVICE NAME: __ PEGASYS Ultra
INDICATIONS FOR USE:
Pegasys Ultra is a nuclear medicine image processing and display workstation that provides software applications used to process, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
### (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 801.109)
OR
Over-The-Counter-Use_ (Optional Format 1-2-96)
David A. Segner
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
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.
