K052305 · Siemens Medical Solutions USA, Inc. · LNH · Sep 8, 2005 · Radiology
Device Facts
Record ID
K052305
Device Name
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
LNH · Radiology
Decision Date
Sep 8, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
Indications for Use
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions. The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration process enables the correction of motion occuring both within-plane and across planes (3D). By aligning corresponding voxels, the software reduces the impact of patient motion in post-processing techniques including difference (subtraction) images, parametric displays, subtraction volume MIPs and mean-curve analysis. Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images.
Device Story
Software plug-in for clinical MRI workstations; processes serial MRI image volumes to correct for patient motion. Inputs: multiple MRI image volumes. Operation: performs automatic 2D/3D rigid and non-rigid registration to align corresponding voxels between volumes. Outputs: motion-corrected image volumes. Used in clinical settings by radiologists; integrated into workstation workflows (e.g., Numaris VA21A, Leonardo 2004). Provides high-speed and high-quality modes. Corrected images serve as input for post-processing techniques like subtraction images, parametric maps, and mean-curve analysis. Benefits: reduces motion-related artifacts, improving visualization for clinical interpretation. Decisions must include review of original uncorrected images.
Clinical Evidence
Bench testing only. Validation included risk analysis, design reviews, integration testing (system verification), final acceptance testing, and performance testing on clinical data sets.
Technological Characteristics
MRI image processing software plug-in. Performs automatic 2D/3D rigid and non-rigid registration. Operates on clinical workstations (e.g., Numaris VA21A, Leonardo 2004, MammoReport Plus). Provides two operational modes: high-speed and high-quality. Software-based image registration algorithm.
Indications for Use
Indicated for use in dynamic MRI examinations involving multiple image volumes where patient motion occurred between serial acquisitions. Intended as an adjunctive tool for radiologists to assist in interpretation. Contraindicated for use as the sole basis for patient management decisions; uncorrected images must always be reviewed.
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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## SEP - 8 2005
## 510(k) Summary
Ko523os
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h) and as described in 21 CFR 807.92.
| Submitter<br>(510k Owner) | Siemens Medical Solutions USA, Inc.<br>Computer Aided Diagnosis & Therapy Group<br>51 Valley Stream Parkway<br>Malvern, PA 19355<br>Tel: (610) 448-4530<br>Fax: (610) 219-1419 | | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------------------------|
| Contact | Barry V. Ashar<br>Makromed, Inc.<br>45 Stiles Road<br>Salem, NH 03079<br>Tel: (603) 890-3311<br>Fax: (603) 890-3322<br>bashar@makromed.com | | |
| Date of Preparation | July 7, 2005 | | |
| Device Trade Name | MRI Soft Tissue Motion Correction Software | | |
| Device Common Name | MRI Image Processing Software | | |
| Classification Name | Class II: Picture Archiving and Communications System<br>(21 CFR 892.2050)<br>Product Code LLZ: Image Processing System | | |
| Substantial Equivalence | CADstream v.4.0 | K043216 | Confirma, Inc. |
| | Fusion 7D | K020546 | Mirada Solutions Ltd.<br>(Now Siemens<br>Medical Solutions,<br>Inc.) |
| | Leonardo | K040970 | Siemens Medical<br>Solutions USA, Inc. |
#### Device Description
MRI Soft Tissue Motion Correction Software VA10A provides the functionality to correct soft tissue motion of the MRI image volume between scan times. It supports the correction (registration) of one or more volumes relative to an initially supplied reference volume.
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The product reduces image deformation and displacement in soft tissues shape and location that may occur due to patient motion in between acquisitions of serial MRJ images. Correction of within imaging plane and across- plane motion is supported.
The software corrects for inter-volume rigid displacement and non-rigid deformation between acquired MRI images. This reduces motion-related artifacts in post-processing techniques that use the corrected images as input, for example subtraction images, subtraction volume MIPs, parametric maps and mean-curve analysis.
MRI Soft Tissue Motion Correction is a plug-in module for Numaris VA21A clinical workstation (K020991) or equivalent, Leonardo 2004 (K040970) or equivalent and MammoReport Plus (K042868) or equivalent. The visualization application invokes the motion correction device, receives and stores the corrected volumes, and displays the results to the user.
MRI Soft Tissue Motion Correction provides both a high quality and a high-speed operational mode. The high-speed mode is optimized for speed, while the high-quality mode is recommended for cases having moderate to large amounts of patient motion between acquisitions and takes longer to complete.
#### Intended Use
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions.
The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration process enables the correction of motion occuring both within-plane and across planes (3D). By aligning corresponding voxels, the software reduces the impact of patient motion in post-processing techniques including difference (subtraction) images, parametric displays, subtraction volume MIPs and mean-curve analysis.
Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images.
#### Comparison with Predicate Devices
Automatic flexible non-rigid 3D registration of serial patient MRI acquisitions to minimize the impact of patient motion, the primary feature of VA10A software, has been given 510(k) clearance in CADstream v. 4.0 (K043216, Confirma, Inc.). Similar to CADstream, MRI Soft Tissue Motion Correction VA10A software is designed to analyze MRI studies and uses flexible non-rigid registration in 3D.
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Automatic flexible non-rigid as well as rigid registration of pairs of anatomical volumetric (MRI-MRI) images to help the clinician obtain better image visualization has been given 510(k) clearance in Fusion7D (K020546, Mirada Solutions, now Siemens Medical Solutions -- CTI Mirada). MRI Soft Tissue Motion Correction also performs non-rigid deformation on MRI image pairs.
Leonardo 2004 (K040970, Siemens Medical) has already been given 510(k) clearance for providing a host of MRI image processing features. The MRI Soft Tissue Motion Correction VA10A software is a plug-in module to it and adds one specific functionality to it - motion correction for soft tissue images. All other features remain unchanged.
#### Test Summary
The following quality assurance measures were applied to the development of the MRI Soft Tissue Motion Correction Software VA10A in accordance with internal procedures:
Risk Analysis Requirements Reviews Design Reviews Integration testing (System verification) Final acceptance testing (Validation) Performance testing on clinical data sets (Validation)
#### Conclusion
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The MRI Soft Tissue Motion Correction Software VA10A is as safe, as effective, and performs as well as the predicate devices.
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Image /page/3/Picture/1 description: The image shows a logo with a stylized bird figure inside a circle. The bird is drawn with thick, black lines and appears to be in flight. The circle is formed by text that curves around the bird. The text is small and difficult to read, but it seems to be a company or organization name. The overall design is simple and modern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2005
Siemens Medical Solutions USA, Inc. % Ms. Laura Danielson Program Manager, Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K052305
Trade/Device Name: MRI Soft Tissue Motion Correction Software VA10A Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Product Code: LLZ Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Product Code: LNH Regulatory Class: II Dated: August 19, 2005 Received: August 24, 2005
Dear Ms. Danielson:
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 premated noticate 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. Hogdon
Nancy 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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# Indications for Use
510(k) Number (if known): צוב במבחמ
Device Name:
### MRI Soft Tissue Motion Correction Software VA10A
Indications for Use:
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions.
The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration process enables the correction of motion occuring both within-plane and across planes (3D). By aligning corresponding voxels, the software reduces the impact of patient motion in post-processing techniques including difference (subtraction) images, parametric displays, subtraction volume MIPs and mean-curve analysis.
Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Schroeder
Division Slan-Off Division of Reprodu and Radiological Devices
510(k) हा प्रतिदिन प्रति Siemens Medical Solutions)
p. A-1
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.
