S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR paranteters, including spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Device Story
S-scan is a magnetic resonance imaging (MRI) system for musculoskeletal diagnostics. It acquires proton density signals from limbs and spine; transforms signals into cross-sectional images via pulse sequences and reconstruction algorithms. Operated by trained medical professionals in clinical settings. System includes patient table, magnetic unit with display panel, and operating console. Display panel provides real-time sequence preview for patient positioning. Output images are interpreted by radiologists/clinicians to identify anatomical structures and pathologies. Benefits include non-invasive diagnostic visualization of joints and spinal column. Modifications from predicate G-scan include manual patient table, upgraded electronics, new receiving coils (DPA Lumbar, Cervical), modified pulse sequences, and new software release.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, technical specifications, and comparison of imaging performance to predicate devices.
Technological Characteristics
Magnetic resonance diagnostic device. Components: patient table (200kg capacity), magnetic unit, operating console, electronics box. Pulse sequences: SE, TSE, IR, STIR, Gradient Echo, Real Time. Multi-channel reconstruction: SoS technique. Connectivity: PC-based console. Coils: DPA Lumbar, Cervical, Shoulder, Knee, Hand, Foot/Ankle, Flexible.
Indications for Use
Indicated for MR imaging of upper limbs (hand, wrist, forearm, elbow, arm, shoulder), lower limbs (foot, ankle, calf, knee, thigh, hip), and spinal column (cervical, lumbo-sacral sections). For use by trained medical experts.
Regulatory Classification
Identification
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
Special Controls
*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
USA Instruments Magna 5000 Phased Array CTL Spine Coil (K994345)
Submission Summary (Full Text)
{0}------------------------------------------------
K063207
# 510(k) Summary
NOV - 9 2006
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
#### Submitter Information
Carri Graham, Official Correspondent 11460 N. Meridian St., Suite 150 Carmel, IN 46032 (317) 569-9500 X 103 Phone: (317) 569-9520 Facsimile:
Contact Person: Carri Graham
October 19, 2006 Date:
807.92(a)(2)
| Trade Name: | S-scan |
|-------------------------|--------------------------------------------|
| Common Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name(s): | Magnetic resonance diagnostic device |
| Classification Number: | 90LNH |
| 807.92(a)(3) | Predicate Device(s) | |
|-----------------|----------------------------------------------|----------|
| Esaote | G-scan | K042236 |
| Esaote | E-scan Opera | K060956- |
| Siemens | Magnetom C! | K043030 |
| USA Instruments | Magna 5000<br>Phased Array<br>CTL Spine Coil | K994345 |
{1}------------------------------------------------
807.92(a)(4)
### Device Description
## Summary of G-scan modifications
The changes performed on the modified G-scan device (S-scan), with respect to the cleared version - G-scan K042236 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- 1. A new patient table that can be moved only manually. Neither the patient table nor the magnet can rotate from horizontal to vertical position.
- 2. A modified support to hold up the magnet and the gantry.
- 3. A new display panel on the front of the magnet.
- 4. Some different external covers due to the new patient table and support.
- 5. Upgrading of the electronics.
- 6. Two new receiving coils: DPA Lumbar spine coil N.10 and Cervical spine coil N.9
- 7. Modified pulse sequences
- 8. A modified version of the magnet poles and of the gradient coils.
- 9. A new software release.
# S-scan
The system is composed of these main parts:
- 1. Patient positioning table.
- 2. Magnetic unit with the display panel.
- 3. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
- 4. Electronics box with filter panel.
{2}------------------------------------------------
## 807.92(a)(5)
#### Intended Use(s)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR paranteters, including spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
{3}------------------------------------------------
807.92(a)(6)
# Technological Characteristics
| Characteristic | S-scan | G-scan K042236 | Comments |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulse Sequences | Orthogonal Multi-planar Scout | Orthogonal Multi-planar Scout | The S-scan pulse<br>sequences are a<br>modified version<br>of the G-scan<br>pulse sequences<br>as described in<br>the Device<br>Modification<br>Description and<br>Software<br>Description<br>sections. |
| | Spin Echo T1 | Spin Echo T1 | |
| | Spin Echo T2 | Spin Echo T2 | |
| | Spin Echo Proton Density T2 | Spin Echo Proton Density T2 | |
| | Inversion Recovery | Inversion Recovery | |
| | Short TI Inversion Recovery | Short TI Inversion Recovery | |
| | Spin Echo T1 Half Echo | Spin Echo T1 Half Echo | |
| | Spin Echo T1 Half Fourier | Spin Echo T1 Half Fourier | |
| | Turbo Spin Echo T2 weighted<br>(TSE, TSE S, TSE SA, TSE SP) | Turbo Spin Echo T2 weighted<br>(TSE) | |
| | Turbo Multi Echo | Turbo Multi Echo | |
| | Gradient Echo | Gradient Echo | |
| | Short Time Inversion Recovery | Short Time Inversion Recovery | |
| | Gradient Echo (Gradient Echo<br>STIR) | Gradient Echo (Gradient Echo<br>STIR) | |
| | Gradient Echo 3D (Turbo 3D T1) | Gradient Echo 3D (Turbo 3D T1) | |
| | Speed — Spin Echo T2 (SSE-SET2,<br>SSE-SET2 S, SSE-SET2 SA, SSE-<br>SET2 SP) | | |
| | Speed — Spin Echo T2 (SSE-SET2<br># 1-2-3) | | |
| | Real Time | Real Time | |
| Receiving coils | 1 Shoulder coil | 1 Shoulder coil | The linear coil<br>of the DPA<br>Lumbar Spine<br>coil n.10 is equal<br>to the Thoracic—<br>Lumbar Spine<br>coil n.8. The<br>whole coil is<br>equivalent to the<br>Magna 5000<br>Phased Array<br>CTL Spine Coil<br>K994345,<br>available on<br>other<br>commercial<br>scanners.<br>See Device<br>Modification<br>Description<br>section |
| | 2 Knee coil | 2 Knee coil | |
| | 3 Hand coil | 3 Hand coil | |
| | 4 Foot/Ankle coil | 4 Foot/Ankle coil | |
| | 6 Flexible coil | 6 Flexible coil | |
| | 7 Shoulder coil | 7 Shoulder coil | |
| | 9 Cervical Spine coil | 8 Thoracic — Lumbar Spine coil | |
| | 10 Lumbar Spine coil | 9 Cervical Spine coil | |
| Characteristic | S-scan | G-scan K042236 | Comments |
| Multi-channel<br>reconstruction | SoS technique | | This technique is<br>already in place<br>on many multi-<br>channel MRI<br>systems as, for<br>instance,<br>MAGNETOM<br>C! (K043030).<br>See Device<br>Modification<br>Description<br>section. |
| Indications for<br>Use | S-scan is a Magnetic Resonance<br>(MR) system that produces<br>transversal, sagittal and coronal<br>and oblique cross-section images<br>of the limbs, joints and spinal<br>column. It is intended for imaging<br>portions of the upper limb,<br>including the hand, wrist, forearm,<br>elbow, arm and shoulder, imaging<br>portions of the lower limb,<br>including the foot, ankle, calf,<br>knee, thigh and hip and imaging<br>portions of the spinal column,<br>including the cervical and lumbo-<br>sacral sections.<br>S-scan images correspond to the<br>spatial distribution of protons<br>(hydrogen nuclei) that determine<br>magnetic resonance properties and<br>are dependent on the MR<br>parameters, including spin-lattice<br>relaxation time (T1), spin-spin<br>relaxation time (T2), nuclei<br>density, flow velocity and<br>"chemical shift". When interpreted<br>by a medical expert trained in the<br>use of MR equipment, the images<br>can provide diagnostically useful<br>information. | G-scan is a Magnetic Resonance<br>(MR) system that produces<br>transversal, sagittal and coronal<br>and oblique cross-section images<br>of the limbs, joints and spinal<br>column. It is intended for imaging<br>portions of the upper limb,<br>including the hand, wrist, forearm,<br>elbow, arm and shoulder, imaging<br>portions of the lower limb,<br>including the foot, ankle, calf,<br>knee, thigh and hip and imaging<br>portions of the spinal column,<br>including the cervical, thoracic and<br>lumbo-sacral sections.<br>G-scan images correspond to the<br>spatial distribution of protons<br>(hydrogen nuclei) that determine<br>magnetic resonance properties and<br>are dependent on the MR<br>parameters, including spin-lattice<br>relaxation time (T1), spin-spin<br>relaxation time (T2), nuclei<br>density, flow velocity and<br>"chemical shift". When<br>interpreted by a medical expert<br>trained in the use of MR equipment,<br>the images can provide<br>diagnostically useful information. | |
| Characteristic | S-scan | E-scan Opera K060956 | Comments |
| Patient table | Maximum load-bearing capacity =<br>200 kg (approx. 440 lb)<br>fixed height (740 cm)<br>it can be rotated and removed from<br>magnet cavity to facilitate patient<br>positioning and<br>to enable various positions in<br>relation to the region examined<br>washable covering material<br>manual positioning<br>integrated in overall design of<br>equipment. | Maximum load-bearing capacity =<br>200 kg (approx. 440 Ib)<br>fixed height (710 cm)<br>removable from magnet cavity to<br>facilitate patient positioning<br>one section of the bed can be<br>rotated to enable various positions<br>in relation to the region examined<br>washable covering material<br>manual positioning<br>integrated in overall design of<br>equipment. | See Device<br>Modification<br>Description<br>section |
| Magnetic unit<br>display panel | The function of the Display Panel<br>is displaying real time sequences<br>for patient positioning.<br>Present commands:<br>Preview: begins the real time<br>sequence and displays the acquired<br>image on the LCD panel in the<br>selected orientation (sagittal, axial,<br>coronal).<br>Abort: stops the running sequence.<br>integrated in overall design of<br>equipment. | The function of the Display Panel<br>is displaying real time sequences<br>for patient positioning.<br>Present commands:<br>Preview: begins the real time<br>sequence and displays the acquired<br>image on the LCD panel in the<br>selected orientation (sagittal, axial,<br>coronal).<br>Abort: stops the running sequence.<br>integrated in overall design of<br>equipment.…
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.
