K083018 · Ge Healthcare Dynamic Imaging Solutions · LLZ · Nov 14, 2008 · Radiology
Device Facts
Record ID
K083018
Device Name
CENTRICITY PACS WEB DIAGNOSTIC
Applicant
Ge Healthcare Dynamic Imaging Solutions
Product Code
LLZ · Radiology
Decision Date
Nov 14, 2008
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
Centricity PACS Web Diagnostic (Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Story
Centricity PACS Web Diagnostic (Web DX) is an internet-based software system for archiving, transferring, displaying, and processing medical images; inputs include DICOM-compliant images from CT, MR, US, NM, CR, DR, DM, DX, XA, and PT modalities. System operates on standard TCP/IP networks using Intel Pentium-based hardware and Windows OS. Users (physicians, radiologists, technicians) access images via web-based viewer; system facilitates image management and display for clinical review. Does not generate original images; relies on human intervention for interpretation. Benefits include centralized access to diagnostic imaging data across distributed healthcare locations, supporting clinical decision-making through efficient image retrieval and display.
Clinical Evidence
No clinical data. Bench testing only; system verification and validation testing performed to ensure safe and effective operation.
Technological Characteristics
Software-based PACS; operates on Intel Pentium-based hardware; utilizes TCP/IP networking; supports DICOM-compliant modalities; web-based viewer architecture; requires 5 Mpixel resolution monitors for mammography interpretation; no patient contact; no life-sustaining functions.
Indications for Use
Indicated for trained professionals, including physicians, radiologists, nurses, medical technicians, and assistants, to receive, store, communicate, process, and display medical images and data from various imaging sources (CT, MR, US, NM, CR, DR, DM, DX, XA, PT). Contraindicated for primary image interpretation of lossy compressed mammographic images and digitized film screen images; mammographic interpretation requires FDA-approved 5 Mpixel resolution monitors.
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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K053018
GE Healthcare Integrated IT Solutions
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular border. There are decorative flourishes around the letters, adding to the logo's distinctive appearance. The logo is black and white.
#### 510(k) Summary Section 5:
NOV 1 4 2008 GE Healthcare Dynamic Imaging Solutions Submitter: 40 Boroline Road Allendale, NJ 07401 Contact Person: Jillian M. Reed Consultant Reed Technical Associates, LLC Date Prepared: October 7, 2008 Picture Archiving Communications System Classification Name: Proprietary Name: Centricity PACS Web Diagnostic (Web DX) PACS System Predicate Devices: #K072986 IntegradWeb™ PACS System by GE Healthcare Dynamic Imaging Solutions #K043415 Centricity PACS System by GE Medical Systems
#### Device Description:
Centricity PACS Web Diagnostic (Web DX) PACS System is an Internet bases software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS Web Diagnostic (Web DX) PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentiumbased) and operating systems (Microsoft Windows 2000, Windows 98). The system does not produce any original medical images. All images located on Centricity PACS Web Diagnostic (Web DX) PACS System have been received from DICOM compliant modalities and/or systems.
#### Intended Use:
Centricity PACS Web Diagnostic (Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, which has decorative elements resembling small, stylized leaves or flourishes around the perimeter.
# GE Healthcare Integrated IT Solutions
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
### Technical Characteristics:
This device is a medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
### Substantial Equivalence:
Testing performed has shown that the Centricity PACS Web DX) PACS System incorporating the new connector and streaming service allowing for images stored in the Centricity PACS System (CPACS) to be viewed on the web-based viewer of the Centricity PACS IW™ is substantially equivalent to the above referenced predicate devices.
#### Discussion of Non-Clinical Testing Performed:
Thorough system verification and validation testing was performed to ensure the safe and effective use of the Centricity PACS Web Diagnostic (Web DX) PACS System.
### Conclusions:
The information provided in this special premarket notification submission has shown that the Centricity PACS Web Diagnostic (Web DX) PACS System is substantially equivalent to the predicate device and is safe and effective for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## NOV 1 4 2008
GE Healthcare Dynamic Imaging Solutions % Ms. Jillian M. Reed Consultant Reed Technical Associates, LLC 25 Walnut Street MONROE CT 06468
- Re: K083018
Trade/Device Name: Centricity PACS Web Diagnostic (Web DX) PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 7, 2008 Received: October 16, 2008
#### Dear Ms. Reed:
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.
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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 (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.
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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 yours,
hope M. Whang
Joyce M. Whang, Ph.D. Acting 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)
Indications for Use
510(k) Number (if known): K083018
Device Name: Centricity PACS Web Diagnostic (Web DX) PACS System
Indications for Use:
Centricity PACS Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicallyd, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed matther mages and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using and TDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed argepted by FDA.
Typical users of this system are trained professionals, including but not the physicians, radiologists, nurses, medical technicians, and assistants.
Prescription Use XXX (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)
Helen Reeves
(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number __
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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.
