K961459 · Advanced Technology Laboratories, Inc. · IYO · Mar 26, 1997 · Radiology
Device Facts
Record ID
K961459
Device Name
LEVEL 10 HDI
Applicant
Advanced Technology Laboratories, Inc.
Product Code
IYO · Radiology
Decision Date
Mar 26, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1560
Device Class
Class 2
Attributes
Pediatric
Indications for Use
Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents. Typical examinations using Level 10 HDI are: - General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies. - Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall. - Pediatric scans of organs, superficial, and bony structures. - Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. - Monitoring procedures for infertility studies (other than in vitro fertilization). - First, second and third trimester pregnancy studies. - Prostate, prostate biopsy guidance, and rectal wall studies. - Neonatal head studies. - Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. - Cardiac studies in adults and children. - Monitoring of cardiac function during procedures using transesophageal echocardiography. - Biopsy guidance for tissue or fluid sampling. - Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery - Study of myocardial function in adults - Study of eye anatomy including blood flow in retinal vessels and branches - Study of the esophagus, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe - Study of abdominal and pelvic organs and masses using laparoscopic probe - Examination of organs, masses and vessels during surgical procedures - Study of muscles, ligaments, nerve bundles and connective tissue
Device Story
Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via piezoelectric array scanheads (linear, curved, phased, static). Transforms reflected sound waves into 2D, M-mode, Color Doppler, Pulsed Doppler, and Color Power Angio images. Operated by clinicians in clinical/surgical settings. System software automatically optimizes operating conditions (frame rate, line density, frequency) based on user inputs. Displays real-time thermal and mechanical acoustic output indices. Output used by healthcare professionals for anatomical measurement, diagnosis, and biopsy guidance. Benefits include non-invasive visualization of internal structures and blood flow to support clinical decision-making.
Clinical Evidence
Bench testing only. Conformance to electromechanical safety standards (IEC 601-1, UL 2601-1, IEC 601-1-2) and acoustic output standards (AIUM/NEMA 1992).
Technological Characteristics
Piezoelectric transducer technology; 2.0-10.0 MHz frequency range. Modes: 2D, M-mode, Color Doppler, CW/PW Doppler, Color Power Angio. Software-controlled optimization of frame rate, line density, and frequency. Displays thermal/mechanical indices. Biocompatible patient-contact materials. Standards: IEC 601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, IEC 601-1-2, AIUM/NEMA 1992.
Indications for Use
Indicated for cardiac, peripheral vascular, fetal, ophthalmic, abdominal, pelvic, small parts, pediatric, and transcranial imaging; biopsy guidance; and intraoperative/endoscopic/laparoscopic assessment of organs, vessels, and tissues in adult and pediatric patients.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
ATL HDI 3000
Storz Renaissance A/B Scan
Submission Summary (Full Text)
{0}
510(k) Premarket Notification
MAR 26 1997
ATL Level 10 HDI Ultrasound System
# SECTION 8
## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1) Submitter’s name, address, telephone number, contact person:
Terrence J. Sweeney
Director, Worldwide Quality and Regulatory Affairs
Advanced Technology Laboratories, Inc.
P.O. Box 3003
Bothell, WA 98041-3003
(206) 487-7602
Date prepared: April 10, 1996
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
**Common/ Usual Name**
Diagnostic Ultrasound System with Accessories
**Proprietary Name**
Level 10 HDI Ultrasound System
**Classification Names**
Ultrasonic Pulsed Doppler Imaging System, Product Code 90 IYN, 21 CFR 892.1550
Diagnostic Ultrasonic Scanhead, Product Code 90 ITX, 21 CFR 892.1570
Ultrasonic Pulsed Echo Imaging System, Product Code 90PID, 21 CFR 892.1560
*Handwritten note: 90IYO 3/17/97*
3) Identification of the predicate or legally marketed device:
Advanced Technology Laboratories, Inc. believes that Level 10 HDI is substantially equivalent to the currently marketed ATL HDI 3000 diagnostic ultrasound system and Storz Renaissance A/B Scan.
510(k) Summary of Safety and Effectiveness
Page 1 of 4
{1}
510(k) Premarket Notification
ATL Level 10 HDI Ultrasound System
## 4) Device Description:
Level 10 HDI is a general purpose, mobile, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, 2D Color Doppler, M-mode Color Doppler, Continuous Wave Doppler (CW), Pulsed (PW) Doppler, Color Power Angio (CPA) or in a combination of modes. Level 10 HDI also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. Level 10 HDI has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The Level 10 HDI system is designed to accept a large selection of scanheads with up to three array scanheads and one static probe being connected to the system at any one time. The operator may select among the scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.
The Level 10 HDI system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 10.0 MHz
scanhead types: Linear array
Curved linear array
Phased array
Static probes
Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.
Level 10 HDI has been designed to meet the following electromechanical safety standards:
- IEC 601-1, International Electrotechnical Commission, Medical Electrical Equipment
- UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical
510(k) Summary of Safety and Effectiveness
Page 2 of 4
{2}
510(k) Premarket Notification
ATL Level 10 HDI Ultrasound System
## Equipment
- CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- IEC 601-1-2, Collateral Standard: Electromagnetic Compatibility
## 5) Intended Use:
Level 10 HDI is intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.
Typical examinations using Level 10 HDI are:
- General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, shoulders, thyroid/parathyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures.
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies.
- Prostate, prostate biopsy guidance, and rectal wall studies.
- Neonatal head studies.
- Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- Cardiac studies in adults and children.
- Monitoring of cardiac function during procedures using transesophageal echocardiography.
- Biopsy guidance for tissue or fluid sampling.
- Assessment of cardiac muscle, coronary arteries and great vessels during cardiac surgery
- Study of myocardial function in adults
- Study of eye anatomy including blood flow in retinal vessels and branches
- Study of the esophagus, stomach, biliary sytem, pancreas and gastrointestinal tract using endoscopic probe
- Study of abdominal and pelvic organs and masses using laparoscopic probe
- Examination of organs, masses and vessels during surgical
510(k) Summary of Safety and Effectiveness
Page 3 of 4
{3}
510(k) Premarket Notification
ATL Level 10 HDI Ultrasound System
procedures
- Study of muscles, ligaments, nerve bundles and connective tissue
## 6) Technological Characteristics:
This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler) are the same as predicate devices identified in item 3. Scanhead patient contact materials are biocompatible.
This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1992) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.
The device's acoustic output limits are:
All Applications Other Than Ophthalmic:
| ISPTAd | 720 mW/cm2 | (Maximum) |
| --- | --- | --- |
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index (MI) | 1.9 | (Maximum) |
| ISPPAd | 0 - 700 W/cm2 | (Range) |
Ophthalmic Applications:
| ISPTAd | 50 mW/cm² | (Maximum) |
| --- | --- | --- |
| TIS at Surface / | | |
| Thermal Index (TIC) | 0.1 - 1.0 | (Range) |
| Mechanical Index (MI) | .23 | (Maximum) |
| ISPPAd | 0 - 50 W/cm² | (Range) |
The limits are same as predicate Track 3 devices.
510(k) Summary of Safety and Effectiveness
Page 4 of 4
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.
