ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
K961073 · Atlantis Diagnostics Intl., Inc. · IYO · Feb 19, 1997 · Radiology
Device Facts
Record ID
K961073
Device Name
ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
Applicant
Atlantis Diagnostics Intl., Inc.
Product Code
IYO · Radiology
Decision Date
Feb 19, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1560
Device Class
Class 2
Attributes
Pediatric
Indications for Use
Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents. Typical examinations shall include: - General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies. - Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall. - Pediatric scans of organs. - Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. - Monitoring procedures for infertility applications. - First, second and third trimester pregnancy studies. - Prostate, prostate biopsy guidance, and rectal wall studies. - Neonatal cephalic studies. - Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. - Cardiac studies in adults and children. - Biopsy guidance for tissue or fluid sampling. - Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.
Device Story
Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via piezoelectric scanheads (linear, curved, phased arrays; 2.0-10.0 MHz). Transforms reflected sound waves into 2-D, M-mode, Color Flow Doppler, Color M-mode, Color Power Angio, and Pulsed (PW) Doppler images/audio. Used in clinical settings by healthcare professionals. System software automatically optimizes operating conditions (frame rate, line density, frequency) based on user inputs (field of view, focal depth). Provides anatomical measurements and analysis packages for clinical diagnosis. Includes on-screen display of thermal/mechanical bioeffect indices (TIS/TIB/TIC, MI) per AIUM/NEMA standards. Output assists clinicians in diagnostic decision-making and procedural guidance.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing, adherence to electromechanical safety standards (IEC 601-1, UL 2601-1, C22.2 No. 601.1, IEC 601-1-2), and compliance with acoustic output declaration standards (CEI/IEC 1157:1992, AIUM/NEMA 1992).
Technological Characteristics
Piezoelectric transducer technology; 2.0-10.0 MHz frequency range. Modes: 2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, Pulsed Doppler. Software-controlled parameter optimization (frame rate, line density, center frequency). Standards: IEC 601-1, UL 2601-1, C22.2 No. 601.1, IEC 601-1-2, CEI/IEC 1157:1992, AIUM/NEMA 1992. Mobile form factor; supports two simultaneous scanheads.
Indications for Use
Indicated for diagnostic ultrasound imaging and blood flow analysis in adults and children, including cardiac, peripheral vascular, fetal, abdominal, pelvic, small parts, pediatric, neonatal, transcranial, and ophthalmic applications, as well as biopsy guidance.
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
ATL Ultramark® 9 HDI™
Atlantis Atlas 1.0
Storz Renaissance A/B Scan
Submission Summary (Full Text)
{0}
02-13-1997 04:05PM
31 3014804224
P.03
510(k) Premarket Notification
K961073
Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems
Revision - February 13, 1997
K961073
# SECTION 10
## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 19 1997
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
Atlantis Diagnostics International, Inc. (ADII)
19015 North Creek Parkway, Suite 105
Bothell WA 98011
(206) 487-7602
Date prepared: February 13, 1997
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
Atlas 2.0 Diagnostic Ultrasound System
Hitachi 2.0 Diagnostic 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 90IYD, 21 CFR 892.1560
3) Identification of the predicate or legally marketed device:
ADII believes that Atlas 2.0 / Hitachi 2.0 are substantially equivalent to the currently-marketed ATL HDI 3000 diagnostic ultrasound system. ATL Ultramark® 9 HDI™ diagnostic ultrasound system, Atlantis Atlas 1.0 system and Storz Renaissance A/B Scan.
4) Device Description:
Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. There function is to acquire ultrasound data and display it on a monitor in 2-D, M-mode, 2-D Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed (PW) Doppler or in a combination of modcs. An audio
510(k) Summary of Safety and Effectiveness
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02-13-1997 04:05PM FROM: REGULATORY
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510(k) Premarket Notification K981073
Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems Revision - February 13, 1997
presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.
The Atlas 2.0 / Hitachi 2.0 systems are designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two 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 Atlas 2.0 / Hitachi 2.0 system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 10.0 MHz
scanhead types: flat linear array
curved linear array
phased array
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.
Atlas 2.0 / Hitachi 2.0 have 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 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:
Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, fetal imaging and other, and ophthalmic intended uses as defined FDA guidance documents.
Typical examinations shall include:
- General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies.
- Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
- Pediatric scans of organs.
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility applications.
- First, second and third trimester pregnancy studies.
- Prostate, prostate biopsy guidance, and rectal wall studies.
- Neonatal cephalic studies.
- Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- Cardiac studies in adults and children.
- Biopsy guidance for tissue or fluid sampling.
510(k) Summary of Safety and Effectiveness
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02-13-1997 04:06PM FROM ATL REGULATORY
114804224 P.05
510(k) Premarket Notification
K961073
Atlantis Atlas 2.0 / Hitachi 2.0 Ultrasound Systems
Revision - February 13, 1997
- Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.
## 6) Technological Characteristics:
These devices operate identical to the predicate devices in that piezo 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 2-D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of these devices (2-D, 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 and are also the same as the identified predicate devices.
These devices conform 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:
| I_{SPTA4} | 720 mW/cm2 | (Maximum) |
| --- | --- | --- |
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index (MI) | 1.9 | (Maximum) |
| I_{SPPA4} | 0 - 700 W/cm2 | (Range) |
Ophthalmic Applications:
| I_{SPTA4} | 50 mW/cm² | (Maximum) |
| --- | --- | --- |
| Thermal Index (TIC) | 0.1 - 1.0 | (Range) |
| Mechanical Index (MI) | .23 | (Maximum) |
| I_{SPPA4} | 0 - 50 W/cm² | (Range) |
The limits are same as predicate Track 3 devices.
510(k) Summary of Safety and Effectiveness
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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.
