K102489 · Toshiba Medical Systems Corporation, Japan · LNH · Aug 2, 2011 · Radiology
Device Facts
Record ID
K102489
Device Name
VANTAGE TITAN 3T
Applicant
Toshiba Medical Systems Corporation, Japan
Product Code
LNH · Radiology
Decision Date
Aug 2, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Indications for Use
Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are: · Proton density (PD) (also called hydrogen density) - · Spin-lattice relaxation time (T1) - · Spin-spin relaxation time (T2) - · Flow dynamics - · Chemical Shift Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Device Story
Vantage Titan 3T is a 3 Tesla MRI system; utilizes 1.6m short magnet; incorporates Pianissimo scan noise reduction technology. Inputs: nuclear magnetic resonance signals from protons in body tissues/fluids. System transforms signals into cross-sectional images (transaxial, coronal, sagittal, oblique) representing proton density, T1/T2 relaxation times, flow dynamics, and chemical shift. Operated by trained clinicians in clinical settings. Output: diagnostic images for physician interpretation to aid clinical decision-making. Features include optional wireless gating, 16-channel (standard) or 32-channel (optional) receiver, and 2-channel RF amplifier. Benefits include high-field diagnostic imaging capabilities for anatomical assessment.
Clinical Evidence
Bench testing performed per IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-33 (2002) + Amd.1/2, NEMA MS1-MS5, and ACR/NEMA DICOM 3.0. Volunteer studies conducted to verify imaging performance. No clinical diagnostic trials reported.
Technological Characteristics
3T MRI system; 1.6m short magnet; 50x50x45 cm field of view. RF frequency 123MHz; 2-channel RF amplifier; 16/32-channel receiver. Pianissimo noise reduction technology. Optional wireless gating. Compliance with IEC 60601-2-33. Software-controlled SAR, dB/dt, and distortion correction. Biocompatibility confirmed for wireless gating accessories.
Indications for Use
Indicated for diagnostic imaging of head or body anatomic structures in patients requiring cross-sectional transaxial, coronal, sagittal, or oblique MRI, including non-contrast MRA. Contraindicated for use with contrast agents not approved for specific indications.
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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Toshiba America Medical Systems, Inc. AUG – 2 2011 Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T
Attachment 1
## 510(k) SUMMARY
Magnetic Resonance Diagnostic Device Accessory 1. DEVICE NAME: MRT-3010/A5 Model Name: Trade/Proprietary Name: Vantage Titan 3T
#### 2. ESTABLISHMENT REGISTRATION:
- U.S. Agent Name and Address: Toshiba America Medical Systems, Inc. 3. 2441 Michelle Drive Tustin, Ca 92780
| Contact Person: | Paul Biggins<br>(714) 730 - 5000 | |
|---------------------|----------------------------------|--|
| Manufacturing Site: | TOSHIBA CORPORATION | |
- 4. TOSHIBA CORPORATION lanufacturing Site: MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- ડ. August 30, 2010 DATE OF SUBMISSION: .
#### 6. DEVICE DESCRIPTION
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan 3T provides the maximum field of view of 50 x 50 x 45 cm.
The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.
- . Field strength of magnet has been changed to 3T.
- . RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
- . Number of RF amplifier channels is increased from 1 to 2.
- Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
- Software platform has been changed. .
NOTE: The Filed Strength Vantage Titan 3T MRJ System is equivalent to that of the SIEMENS Verio, which is cleared on October 10, 2007 (K072237).
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Attachment 1
## 6.1. SUMMARY OF MAJOR HARDWARE CHANGES
- Field strength of magnet has been changed to 3T. a.
- RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in b. resonance frequency (63MHz -> 123MHz).
- Number of RF amplifier channels is increased from 1 to 2. C.
- Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for d. optional.
- Cooling fan box is separated from filter cabinet. e.
- Transformer cabinet has been modified to cover the system power requirement. f.
- Wireless gating is added (optional). g.
#### SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.
- New RF amplifier cabinet control. a.
- b. New gradient power supply control.
- New Magnet supervisory control. c.
- d. Modified the data base for SAR control for new WB coil.
- Modified the data base for distortion correction and dB/dt calculation for new gradient e. coil.
- f. New software platform.
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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T
K102484
p3/4
### 7. SAFETY PARAMETERS
Attachment l
| | EXCELART Vantage Titan<br>(K080038) | New Vantage Titan 3T |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| a. Static field strength: | 1.5 T | 3T |
| b. Peak and A-weighted<br>acoustic noise: | 105.7dB (A-weighted)<br>115.7dB (peak) | 111.8 dB (A-weighted)<br>121.3 dB (peak) |
| c. Operational modes:<br>i. Safety parameter<br>display: | 1st operating mode<br>SAR, dB/dt | Same |
| ii. Operating mode access<br>requirements: | Allows access to 1st level<br>operating mode | Same |
| d. Maximum SAR | 4 W/kg for whole body (1st<br>operating mode specified in IEC<br>60601-2-33 (2002)) | Same |
| e. Maximum dB/dt | <1st operating mode specified in<br>IEC 60601-2-33 (2002) | Same |
| and Gradient coil<br>dimensions: | 760 x 893 x 1405<br>(inner diameter x outer diameter x<br>length, unit: mm) | 749 x 893 x 1405<br>(inner diameter x outer diameter<br>x length, unit: mm) |
| f. Potential emergency<br>conditions and means<br>provided for shutdown: | Shut down by Emergency Ramp<br>Down Unit for collision hazard by<br>ferromagnetic objects | Same |
| g. Biocompatibility of<br>materials: | Not applicable | Confirmed for electrodes and<br>accessories for wireless gating |
## 8. IMAGING PERFORMANCE PARAMETERS
No changes from the previous submission, K080038.
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## Attachment 1
#### 9. INTENDED USE
Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
· Proton density (PD) (also called hydrogen density)
- · Spin-lattice relaxation time (T1)
- · Spin-spin relaxation time (T2)
- · Flow dynamics
- · Chemical Shift
Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
#### 10. EQUIVALENCY INFORMATION
Toshiba Medical Systems Corporation believes that the Vantage Titan 3T (model MRT-3010/A5) Magnetic Resonance Imaging (MRI) System is substantially equivalent to the current Vantage Titan (model MRT-1504/S3) cleared on January 22, 2008 (K080038) except for magnetic field strength (3T instead of 1.5T). Field strength of this system is equivalent to that of SIEMENS Verio, which is cleared on October 10, 2007 (K072237).
Testing was done in accordance with applicable recognized consensus standards as listed below. Additionally, volunteer studies were conducted to verify imaging performance.
IEC 60601-1-1 IEC 60601-1-2 IEC 60601-2-33(2002) + Amd.1 (2005) + Amd.2 (2007) NEMA MS1, MS2, MS3, MS4, MS5 ACR/NEMA DICOM 3.0
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Toshiba Medical Systems Corporation, Japan % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
AUG - 2 2011
Re: K102489
Trade/Device Name: Vantage Titan 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and MOS Dated: April 8, 2011 Received: April 18, 2011
Dear Mr. Biggins:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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# K102489
# Indications for Use
510(k) Number (if known):
Device Name: Vantage Titan 3T
Indications for Use:
Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- Proton density (PD) (also called hydrogen density)
- Spin-lattice relaxation time (T1) ·
- . Spin-spin relaxation time (T2)
- Flow dynamics
- Chemical Shift
Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Prescription Use (Part 21 CFR 801Subpart D) 801Subpart C)
OR
Over-The-Counter Use (Part 21 CFR
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S Patel
---
(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K102-189
Company Confidential AUG 2010
510(k): Vantage Titan 3T Page 37 of 3857
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.
