K060003 · Toshibamedical Systems Corporation · LNH · Jan 18, 2006 · Radiology
Device Facts
Record ID
K060003
Device Name
EXCELART VANTAGE ZGV
Applicant
Toshibamedical Systems Corporation
Product Code
LNH · Radiology
Decision Date
Jan 18, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Attributes
3rd-Party Reviewed
Indications for Use
Imaging of: The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] Fluid Visualization . 2D / 3D Imaging MR Angiography / MR Vascular Imaging . Blood Oxygenation Level Dependent (BOLD) imaging ● Perfusion / Diffusion Imaging . Proton Spectroscopy .
Device Story
EXCELART Vantage™ ZGV is a 1.5T MRI system; utilizes magnetic resonance to generate diagnostic images of human anatomy. Inputs: RF signals and magnetic field gradients; processed via system CPU (3.2GHz) to reconstruct 2D/3D images. System features upgraded gradient coils and power supply for higher strength/slew rates compared to predicate. Operated by trained clinicians/technicians in clinical settings. Output: Diagnostic images for physician review to aid clinical decision-making. Benefits: Enhanced imaging performance (Min.TR/TE/Slice thickness) and expanded coil compatibility (Flex coils, QD Knee/Foot). Supports 1st level SAR operating mode per IEC 60601-2-33.
Clinical Evidence
Bench testing only. No clinical data provided. Imaging performance parameters were verified as unchanged from the previous submission (K032490).
Technological Characteristics
1.5T MRI system. Hardware: Upgraded gradient coils and power supply. CPU: 3.2GHz. Connectivity: Supports various RF coils (Flex, QD Knee/Foot). Safety: Complies with IEC 60601-2-33 (2002) for 1st level SAR operating mode. Imaging: 2D/3D, BOLD, perfusion/diffusion, proton spectroscopy. Software: Controls RF coils and SAR limitations.
Indications for Use
Indicated for whole-body MRI imaging, including head, abdomen, pelvis, extremities, spine, neck, TMJ, heart, and vasculature. Supports 2D/3D imaging, angiography, BOLD, perfusion/diffusion, and proton spectroscopy. No specific age or gender contraindications listed.
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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# JAN 1 8 2006
06 0003
Appendix 1
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|--------------------------------|------------------------------------------------|
| Model Name: | MRT-1503/P5 |
| Trade/Proprietary Name: | EXCELART Vantage™ ZGV |
| 2. ESTABLISHMENT REGISTRATION: | 2020563 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 3. U.S. Agent Name and Address: 2441 MICHELLE DRIVE TUSTIN, CA 92780
Paul Biggins Contact Person: (714) 730 - 5000
- TOSHIBA CORPORATION Manufacturing Site: 4. MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- December 22, 2005 DATE OF SUBMISSION: 5.
#### DEVICE DESCRIPTION 6.
The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.
- The maximum gradient strength and the maximum slew rate have been increased. .
- The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz. ,
- SAR 1st level operating mode as specified in IEC 60601-2-33 (2002). .
- Thel performance (Min.TR/Min.TE / Min.Slice thickness ) of a sequence has been , improved.
| Model Number with suffix | Trade/Proprietary Name |
|--------------------------|------------------------|
| MRT-1503/P5 | EXCELART Vantage™ ZGV |
# 6.1. SUMMARY OF MAJOR HARDWARE CHANGES
- A. The gradient coil was changed for higher gradient strength and slew rate .
- B. The gradient power supply was changed for higher gradient strength and slew rate.
- C: The clock of CPU was changed from 2.8GHz to 3.2GHz.
- D. Flex coils (70, 100, 150, 200mm, Rectangular) are added to the available coil list.
- E. QD Knee/Foot coil ( K051763) is added.
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# 6.2. SUMMARY OF MAJOR SOFTWARE CHANGES
- A. New CPU correspondence.
- B. New RF coil control.
- C. SAR limitation control.
## 7. SAFETY PARAMETERS
| | Current EXCELART<br>Vantage™ XGV/AGV (No<br>changes from the previous<br>submission, K032490 ) | New EXCELART<br>Vantage™ ZGV |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted<br>acoustic noise: | 110 dB (A-weighted) | Same |
| c. Operational modes: | 1st operating mode for dB/dt | 1st operating mode<br>for dB/dt and SAR |
| i. Safety parameter display: | SAR, dB/dt | Same |
| ii. Operating mode access<br>requirements: | Not applicable because used<br>only in normal operating<br>mode | Allows access to 1st<br>level operating mode |
| d. Maximum SAR | Normal operating mode<br>specified in IEC 60601-2-33<br>(2002) | 1st operating mode<br>specified in IEC<br>60601-2-33 (2002) |
| e. Maximum dB/dt | <1st operating mode specified<br>in IEC 60601-2-33 (2002) | Same |
| and Gradient coil dimensions: | 692 x 893 x 1405<br>(unit: mm) | Same |
| f. Potential emergency<br>conditions and means provided<br>for shutdown: | Shut down by Emergency<br>Ramp Down Unit for collision<br>hazard by ferromagnetic<br>objects | Same |
| g. Biocompatibility of materials: | Not applicable | Same |
#### IMAGING PERFORMANCE PARAMETERS 8.
No changes from the previous submission, K032490 .
## 9. INTENDED USE
No changes from the previous submission, K032490 .
# 10. EQUIVALENCY INFORMATION
TOSHIBA Medical Systems Corporation believes that the new EXCELART Vantage™ ZGV (model MRT-1503/P5) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) (K032490 ) cleared on August 21, 2003.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2006
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K060003 Trade/Device Name: Excelart Vantage™ ZGV Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 29, 2005 Received: January 3, 2006
Dear Mr. Job:
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 adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brigdon
Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Attachment 1
# Indications for Use
510(k) Number (if known):
Device Name: EXCELART Vantage™ ZGV
Indications for Use:
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, t t neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
- Fluid Visualization .
- . 2D / 3D Imaging
- MR Angiography / MR Vascular Imaging .
- Blood Oxygenation Level Dependent (BOLD) imaging ●
- Perfusion / Diffusion Imaging .
- Proton Spectroscopy .
Prescription Use
(Part 21 CFR 801Subpart D)
OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel R. Seymour
(Division Sign-Off) Division of Reproductive, Abdon and Parlicipal Devices 510K, NUMBER ______________
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.
