K032656 · Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · IYN · Oct 30, 2003 · Radiology
Device Facts
Record ID
K032656
Device Name
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
Applicant
Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
Product Code
IYN · Radiology
Decision Date
Oct 30, 2003
Decision
SESE
Submission Type
Special
Regulation
21 CFR 892.1550
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Device Story
GE LOGIQ 9 is a mobile, general-purpose diagnostic ultrasound system; console-based with digital acquisition, processing, and display. Inputs include ultrasonic signals from various probes; system processes these via digital beamforming and image enhancement algorithms (including IQ filter/Speckle Reduction Imaging). Outputs are displayed on CRT/LCD monitors for physician interpretation. Used in clinical settings by physicians for diagnostic imaging; aids in clinical decision-making by providing real-time anatomical and physiological visualization. Benefits include improved image quality and diagnostic capability through enhanced user interface and processing features.
Clinical Evidence
No clinical data required. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with applicable standards.
Technological Characteristics
Mobile console-based ultrasound system; digital acquisition and processing. Features IQ filter and Speckle Reduction Imaging. Connectivity via standard ultrasound interfaces. Conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485. Safety verified per medical device standards for acoustic output, electrical, and mechanical safety.
Indications for Use
Indicated for ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal, urological (prostate), transvaginal, and intraoperative applications by qualified physicians.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
GE LOGIQ 9 Diagnostic Ultrasound System (K011188/K030934)
Submission Summary (Full Text)
{0}------------------------------------------------
K 032656
Special 510(k) Premarket Notification GE Medical Systems - LOGIQ 9 Ultrasound BT03/IQ August 26, 2003
### OCT 3 0 2003
## Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
| | | | <i>GE Medical Systems</i> |
|--|--|-----------------------------------------------------------------------------|---------------------------|
| | | <i>General Electric Company</i><br><i>P.O. Box 414, Milwaukee, WI 53201</i> | |
**Section a):**
| 1. Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC<br>PO Box 414<br>Milwaukee, WI 53201 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allen Schuh,<br>Manager, Safety and Regulatory Engineering<br>Telephone: 414-647-4385; Fax: 414-647-4090 |
| Date Prepared: | August 26, 2003 |
| 2. Device Name: | GE LOGIQ 9 Diagnostic Ultrasound System with IQ Filter,<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |
| 3. Marketed Device: | GE LOGIQ 9 Diagnostic Ultrasound System K011188/K030934 (90-IYO/IYN)<br>A device currently in commercial distribution. |
4. Device Description: The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide. 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and image enhancement.
5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
6. Comparison with Predicate Device: The GE LOGIQ 9 with the IQ filter is of a comparable type and substantially equivalent to the current GE LOGIQ 9. It has the same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device.
#### Section b):
1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
#### 2. Clinical Tests: None required.
3. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 9 BT03 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# OCT 3 0 2003
Mr. Allen Schuh Manager, Safety & Regulatory Engineering GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue MILWAUKEE WI 53219
### Re: K032656
Trade/Device Name: GE LOGIQ 9 Diagnostic Ultrasound System (added: Speckle Reduction Imaging) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging syster Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN. IYO, and ITX Dated: October 1, 2003 Received: October 2, 2003
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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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.
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.
