CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.
Device Story
CentarisOne RIS/PACS is a DICOM and IHE-compliant software system for small to mid-sized imaging centers. It integrates radiology information system (RIS) patient data with picture archiving and communication system (PACS) image management. The system stores, distributes, and displays medical images from various modalities (CT, MRI, NM, PT, DR, CR, US, XA). Physicians and medical staff use the system to access patient information and images, facilitating clinical workflow. The device does not perform primary diagnostic viewing for mammography. It operates as a software solution within a clinical environment to support image management and clinical decision-making.
Clinical Evidence
Bench testing only. The device was tested in non-clinical and clinical locations to verify safety and effectiveness. A risk and hazards analysis was performed, with the level of concern classified as minor.
Technological Characteristics
Software-based RIS/PACS solution. DICOM and IHE compliant. Does not contact patients; does not control life-sustaining equipment. Operates as a networked system for image storage and display. Software developed under written procedures and quality controls.
Indications for Use
Indicated for use by physicians and medical staff for storage, distribution, and display of medical images from CT, MRI, NM, PT, DR, CR, US, XA, and secondary capture devices. Includes mammography image archiving, excluding primary diagnostic viewing of mammography.
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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K063037
#### 510(k) Summary
# OCT 1 8 2006
Per Title 21 CFR 807.92, and in accordance with the provisions of the SMDA 1990. CentarisOne, LLC is providing a summary of the safety and effectiveness information regarding the CentarisOne RIS/PACS system.
#### Date Prepared
August 26, 2006
#### Submitters Information:
CentarisOne, LLC 11925 Wilshire Blvd., Suite 301 Los Angeles, Ca. 90025 Establishment Registration: REGISTRATION NUMBER Contact: Scott Shannon, Product Director (888) 747-2002 ext. 114 (phone) (866) 816-2437 (fax)
#### Device Name:
| Proprietary Name: | CentarisOne™ RIS/PACS |
|------------------------|------------------------------------------------------|
| Common Name: | Picture Archiving and Communication System<br>(PACS) |
| Product Code: | LLZ |
| Device Classification: | Class II - 892.2050 |
| Classification Name: | System, Image Processing, Radiological |
#### Predicate Device:
| | The CentarisOne™ RIS/PACS system is substantially equivalent to the |
|-----------------------------|---------------------------------------------------------------------|
| Manufacturer: | Intuitive Imaging Informatics, LLC |
| Device: | IMAGEQUBE PACS |
| 510(k) Number: | K051037 |
| Decision Date: | 06/28/2005 |
| Decision: | Substantially Equivalent |
| Product Code: | LLZ |
| Device Classification Name: | System, Image Processing, Radiological |
| Device Classification: | Class II - 892.2050 |
#### Device Description:
The CentarisOne™ RIS/PACS is a comprehensive DICOM and IHE compliant radiology software based solution for small to mid-sized imaging centers. The RIS maintains control over all patient related information. The product integrates the imaging aspect with the front office details of the imaging center. It provides all users of the system with more information about the activities of a patient. This all leads to a smoother workflow and better patient care. The PACS component manages the image storage and image display to end-users while
| September 5, 2006 |
|--------------------|
| 510k-100-00001-001 |
CentarisOne™ 510(k) Submission
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tightly integrated into the radiology information system (RIS) to provide users with more patient information resulting in a tighter work-flow.
# Indications for Use:
CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.
# Substantial Equivalence to Predicate Device:
There are no significant differences between CentarisOne RIS/PACS and IMAGEQUBE PACS device. Both devices provide a comparable set of features for image storage, communication and display. Both devices support standard DICOM protocol for communication of images with other medical imaging devices.
# Technology Characteristics:
The device does not come in contact with the patient and does not control any life sustaining devices. The PACS device only stores and displays DICOM images to physicians and other professional clinical staff. The application software is designed, developed and tested using written procedures and quality controls.
# Safety:
The device has been tested in non-clinical and clinical locations and proven to be safe and effective. The device contains instructions for use and warnings or cautions to provide for the safe and effective use of the device.
A risk and hazards analysis for the device is included with the 510(k) submission and the "Level of Concern" for potential hazards has been classified as "minor".
# Conclusion:
The CentarisOne™ RIS/PACS product acquires, processes, archives and distributes images utilizing similar techniques functions and techniques as the predicate device IMAGEQUBE PACS.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest the head and body.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
# OCT 1 8 2006
CentarisOne, LLC c/o Morten Simon Christensen Staff Engineer & FDA Office Coordinator Medical Device Services Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131
Re: K063037
, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Trade/Device Name: CentarisOne" RIS/PACS Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system " Regulatory Class: II Product Code: LLZ Dated: October 2, 2006 Received: October 3, 2006
Dear Mr. Christensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rotened your becation on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass butted in are 1976, the enactment date of the Medical Device Amendments, or to devices that prov to thay Boy 1770, and cordance with the provisions of the Federal Food, Drug, and Cosmetic Ital (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 therefore, mainter 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 tryour do roo is election (oo arch additional controls. Existing major regulations affecting your Apploraly, it they of secret to east Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in a bold, stylized font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted circle with text that reads "U.S. Department of Health & Human Services".
cting and Promoting Public Health
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Page 2 -
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): _ K 6 6 3 6 3 7
Device Name: CentarisOne RIS/PACS
Indications for Use:
CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.
Prescription Use 1 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Segerson
of Reproductive. A
CentarisOne™ 510(k) Submission
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Learn the FDA Browser
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.
