K962138 · Toshiba America Mri, Inc. · LNH · Dec 23, 1996 · Radiology
Device Facts
Record ID
K962138
Device Name
FLEXART V3.1 SOFTWARE
Applicant
Toshiba America Mri, Inc.
Product Code
LNH · Radiology
Decision Date
Dec 23, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Indications for Use
Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart Nuclei excited: Hydrogen Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy.
Device Story
FLEXART™ V3.1 is an MRI system upgrade (MRT-50GP/E2 and MRT-50GP/H1) for the existing FLEXART™ platform. The system uses magnetic resonance to acquire anatomical images of the head, body, extremities, spine, neck, TMJ, and heart. The E2 model introduces new application features (FastASE, QuadScan, MR Fluoroscopy, MSOFT, PASTA); the H1 model increases gradient field strength. Operated by trained clinical staff in a radiology setting, the device transforms magnetic resonance signals into diagnostic images. Output is viewed by physicians to assess anatomy and pathology, aiding clinical decision-making. Benefits include improved image quality and expanded scanning capabilities (e.g., fat suppression, fluoroscopy) compared to the base model. Patient safety is managed via acoustic noise protection.
Clinical Evidence
Bench testing only. Performance was validated using sample phantom images and clinical images for all new sequences. Conformance with consensus standards was demonstrated for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing.
Technological Characteristics
Magnetic resonance imaging system; 0.5 T static field strength; gradient field strength up to 13.3 T/sec (τ=1000ms); RF power deposition <0.34 W/kg. Software version 3.1 includes new sequences (FastASE, QuadScan, MSOFT, PASTA). Operates on hydrogen nuclei excitation. Acoustic noise levels <100 dB(A).
Indications for Use
Indicated for whole-body diagnostic imaging, including head, abdomen, heart, pelvis, spine, blood vessels, and extremities, utilizing hydrogen nuclei excitation for fluid visualization, 2D/3D imaging, MR angiography, and MR fluoroscopy.
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.
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DEC 23 1996
K962138
# 510(k) Summary
## SUMMARY OF SAFETY AND EFFECTIVENESS
1. Model Name: MRT-50GP/E2 and MRT-50GP/H1
Device Name: Magnetic Resonance Device
Trade/Proprietary Name: FLEXART™ V3.1
2. Establishment Registration: #2936923
3. U.S. Agent Name and Address: TOSHIBA AMERICA MRI, INC.
280 Utah Ave.
South San Francisco, CA 94080
Contact Person: Steven M. Kay
(714) 730-5000
4. Manufacturing Site: Toshiba Corporation
1385 Shimoishigami
Otawara-shi, Tochigi-Ken
Japan 324
5. DATE OF SUBMISSION: May 30 1996
6. DEVICE DESCRIPTION
Version 3.1 software consists of two model upgrades to the FLEXART™ system. The MRT-50GP/E2 (Flexart™) includes such new applicational features as FastASE, QuadScan and MR Fluoroscopy for scanning and MSOFT and PASTA for fat suppression. The MRT-50GP/H1 (Flexart™/Hyper) increases the gradient field strength over that of the Flexart™.
7. SAFETY PARAMETERS
| | MRT-50GP | MRT-50GP/E2 | MRT-50Gf/H1 |
| --- | --- | --- | --- |
| Maximum static field strength: | 0.5 T | Same | Same |
| Rate of change of magnetic field (τ = 1000ms): | 11 T/sec, | Same | 13.3 T/sec. |
| Max. Radio frequency power deposition: | <0.256 W/kg | Same | <0.34 W/kg |
| Acoustic Noise levels: | 100.2 dB (A) | Same | 98.5 dB (A) |
| | (Maximum) | (Maximum) | (Maximum) |
Acoustic noise data was measured in accordance with NEMA guidelines. The user is cautioned to have the patient wear acoustic noise protection during scanning, thus ensuring that the patient observed noise level is significantly below 100 dB (A).
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510(k) Summary (cont'd)
SUMMARY OF SAFETY AND EFFECTIVENESS
## 8. IMAGING PERFORMANCE PARAMETERS
| Specification volume: | Head: | MRT-150A | MRT-150/H1 | MRT-150/F1 |
| --- | --- | --- | --- | --- |
| | | 10.4 cm dsv | 14 cm dsv | 14 cm dsv |
| | Body: | 10.4 cm dsv | 28 cm dsv | 28 cm dsv |
Sample phantom images and clinical images were presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing.
## 9. INTENDED USE
Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart
Nuclei excited: Hydrogen
Diagnostic Use: Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy.
## 10. EQUIVALENCE INFORMATION
Toshiba America Medical Systems, Inc. (TAMS) believes the FLEXART™ and FLEXART™/HYPER systems with V3.1 are substantially equivalent to the MRT-50GP FLEXART™ because they consist of hardware and software upgrades that improve the performance of the basic FLEXART™, without introducing new questions of safety or efficacy. The FLEXART™ was cleared by K933018. The increased gradient field strength is less than the IEC standard and that of other manufacturers systems currently on the market. New surface coils for this system received prior market clearance from the Agency. Software upgrades provide for improved image quality, but do not change the intended uses of the device. MR Fluoroscopy is similar to the same function that was cleared for the MRT-35A. Good Manufacturing Practices requirements are unchanged from those already in effect for the FLEXART™.
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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.
