K072952 · General Electric Co. · LLZ · Nov 16, 2007 · Radiology
Device Facts
Record ID
K072952
Device Name
GE ECHOPAC
Applicant
General Electric Co.
Product Code
LLZ · Radiology
Decision Date
Nov 16, 2007
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, Pediatric
Indications for Use
The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional; Peripheral Vascular; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Device Story
GE EchoPAC is an ultrasound image analysis and review workstation; optimized for images acquired via GE Vivid diagnostic ultrasound systems. Device functions as a post-acquisition review tool for clinicians; enabling analysis of B, M, Color M, Color, Power, Pulsed/CW Doppler, Coded Pulse, Harmonic, and Realtime 3D modes. Used in clinical settings; operated by healthcare professionals. Output allows clinicians to review and analyze diagnostic images to support clinical decision-making. Benefits include efficient management and review of ultrasound data.
Clinical Evidence
No clinical data required. Bench testing performed to confirm conformance to design specifications, software development standards, and system compatibility. Reliability evaluated within the intended network environment.
Technological Characteristics
Ultrasound image analysis workstation; software-based. Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485:2000. Operates on computer hardware certified to applicable safety standards. Connectivity via network integration for image management.
Indications for Use
Indicated for diagnostic review and analysis of ultrasound images in patients requiring fetal, abdominal, urological, pediatric, small organ, neonatal/adult cephalic, cardiac, musculoskeletal, peripheral vascular, transesophageal, transrectal, transvaginal, or intraoperative ultrasound assessment.
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
GE Vivid 7 Diagnostic Ultrasound with EchoPAC (K060542)
Submission Summary (Full Text)
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K072952
Special 510(k) Premarket Notification GE EchoPAC Ultrasound Workstation - Medical Image Management Device October 17, 2007
## Attachment B:
NOV 1 2005
# Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c).
GE Healthcare
General Electric Company P.O. Box 414, Milwaukee, WI 53201
#### Section a):
| Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics<br>PO Box 414<br>Milwaukee, WI 53201 |
|-----------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Allen Schuh,<br>Manager, Ultrasound Regulatory Affairs<br>Telephone: 414-721-3992; Fax: 414-721-3899 |
| Date Prepared: | October 17, 2007 |
2. Device Name: GE EchoPAC™ Ultrasound Image Workstation System, Image Processing, Radiological , 21 CFR 892.2050, 90-LLZ
3. Marketed Device: GE Vivid 7 Diagnostic Ultrasound with EchoPAC - K060542 Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN4. Device Description: The GE EchoPAC is an Ultrasound image Analysis and Review Workstation optimized for ultrasound images that are acquired primarily via the GE Vivid family of diagnostic ultrasound systems. It is sold either with computer hardware only with hardware specifications.
5. Indications for Use: For diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular)
6. Comparison with Predicate Device: The GE EchoPAC™ is the same device previously cleared as an accessory to the Vivid 7 ultrasound system under K060542. It has the technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has essentially the same intended uses and post acquisition characteristics as the Vivid 7 ultrasound system.
#### Section b):
1. Non-clinical Tests: The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates. Computer hardware is certified to applicable safety standards.
2. Clinical Tests: None required to confirm safety and effectiveness. However, evaluation in a clinical setting is performed to help assure reliability within the intended network environment.
3. Conclusion: Intended uses and other key features of the device are consistent with traditional clinical practice. FDA quidelines and established methods of handling patient examination images and data. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through internal and independent quality system audit. PACS devices and medical information management systems in general have accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE EchoPAC™ is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird with three wing-like shapes above a wavy line.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
#### NOV 1 6 2007
Mr. Allen Schuh Manager, Ultrasound Regulatory Affairs General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226
Re: K072952
Trade/Device Name: GE EchoPACTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2007 Received: October 18, 2007
Dear Mr. Schuh:
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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 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 yours,
Nancy Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Special 510(k) Premarket Notification Special 310(K) Promance Netical Image Management Device October 17, 2007
## Attachment E
### Indications for Use
510(k) Number (if known):
K072952
Device Name: GE EchoPAC™
Indications For Use:
The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications Fetal; Abdominal; Urology (including prostate); include: Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional; Peripheral Vascular; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
logu h'Whing
(Division Division of Reproductive. Abdominal ar Radiological Devices 510(k) Number
E-1
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.
