K121160 · Siemens Medical Solutions USA, Inc. · LNH · Jul 16, 2012 · Radiology
Device Facts
Record ID
K121160
Device Name
MAGNETOM SPECTRA
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
LNH · Radiology
Decision Date
Jul 16, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Indications for Use
The MAGNETOM Spectra is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
Device Story
MAGNETOM Spectra is a 3T superconducting whole-body MRI scanner; utilizes magnetic resonance physics to acquire cross-sectional images, spectroscopic images, and spectra of head, body, and extremities. System features open-bore design for patient comfort; fixed configuration. Operated by trained clinicians/technicians in clinical settings; supports interventional procedures via MR-compatible accessories (e.g., biopsy needles). Output consists of visual images and derived physical parameters; interpreted by physicians to assist in clinical diagnosis. System workflow emphasizes ergonomics and usability. Benefits include non-invasive diagnostic visualization of internal structures and function.
Clinical Evidence
Bench testing only. Performance and safety data measured per NEMA, IEC, and ISO standards, including static field, RF power deposition, acoustic noise, signal-to-noise ratio, image uniformity, geometric distortion, slice profile, and spatial resolution. No clinical data presented.
Technological Characteristics
3T superconducting magnet; open-bore whole-body scanner. Conforms to IEC, ISO, and NEMA standards for MR safety and performance. Fixed configuration. Software-based image reconstruction and processing.
Indications for Use
Indicated for patients requiring diagnostic MR imaging of the head, body, or extremities; produces cross-sectional images, spectroscopic images, and spectra to assist in diagnosis; supports interventional procedures using MR-compatible devices. Contraindications include presence of non-MR-safe implants or devices.
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.
Hardware and Software Updates to MAGNETOM Aera (1.5T) and Skyra (3T) (K111242)
Submission Summary (Full Text)
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510K Summary
# SIEMENS
#### Traditional 510(k) Submission: MAGNETOM Spectra 3T System
# I. General Information
Establishment
Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA
JUL 16 2012
Date Prepared
April 13, 2012
2240869
Registration Number
Manufacturer
Siemens Shenzhen Magnetic Resonance Ltd. Siemens MRI Center Gaoxin C. Ave., 2nd Hi-Tech Industrial Park, Shenzhen 518057, P.R. China
### Registration Number
Contact Person
3004754211
Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist Siemens Healthcare
Siemens Medical Solutions USA, Inc. Customer Solutions Group 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA Phone: (610) 448-4918 Fax: (610) 448-1787
Device Name
Trade Names: MAGNETOM Spectra Classification Name: Magnetic Resonance Diagnostic Device CFR Code: 21 CFR § 892.1000 Classification: Class II
#### Performance Standards
None established under Section 514 the Food, Drug and Cosmetic Act.
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SIEMENS
Traditional 510(k) Submission: MAGNETOM Spectra 3T System
### II. Safety and Effectiveness Information Supporting Substantial Equivalence
### Intended Use
The MAGNETOM Spectra is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
#### Device Description
MAGNETOM Spectra (3T) is similar to the previously cleared MAGNETOM Skyra and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to simplify the MR workflow.
The MAGNETOM Spectra systems will be available in a fixed configuration.
#### Substantial Equivalence
Siemens feels that the new system is substantially equivalent to the following predicate devices:
| Predicate Device Name | FDA<br>Clearance<br>Number | FDA Clearance<br>Date |
|-------------------------------------------------------------------------|----------------------------|-----------------------|
| Siemens MAGNETOM Skyra (3T) | K101347 | October 1, 2010 |
| Siemens MAGNETOM Verio (3T) | K072237 | October 10, 2007 |
| syngo® MR B17 Software update | K082427 | November 7, 2008 |
| Hardware and Software Updates to<br>MAGNETOM Aera (1.5T) and Skyra (3T) | K111242 | November 23, 2011 |
#### General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Spectra system is substantially equivalent to the commercially available MAGNETOM Skyra and MAGNETOM Verio System.
# Siemens 510(k) for MAGNETOM Spectra
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Traditional 510(k) Submission: MAGNETOM Spectra 3T System
As specified in the FDA guidance document "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Devices" (released Nov. 1998) the following measurements of performance and safety data have been performed following NEMA or equivalent IEC and ISO standards:
### Safety:
- Maximum Static Field
- · Rate of Change of Magnetic Field
SIEMENS
- · RF Power Deposition
- · Acoustic Noise Levels
#### Performance:
- · Specification Volume
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution
The MAGNETOM Spectra also conforms to the measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.
Furthermore performance measurements have been done on the predicate devices MAGNETOM Skyra and MAGNETOM Verio to show that the performance of the MAGNETOM Spectra is equivalent with respect to the predicate devices, assuring that the performance of these devices can be considered safe and effective with respect to the currently available MAGNETOM Skyra and MAGNETOM Verio systems.
# Siemens 510(k) for MAGNETOM Spectra
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle.
# 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
Ms. Nadia Sookdeo Technical Specialist, Regulatory Submissions Siemens Medical Solutions, USA, Inc. 51 Valley Stream Parkway, D 02 MALVERN PA 19355
Re: K121160
Trade/Device Name: MAGNETOM Spectra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, KNI, and MOS Dated: April 13, 2012 Received: April 16, 2012
JUL 16 2012
#### Dear Ms. Sookdeo:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section >10(x) promative is substantialy enuivalent (for the indications
referenced above and have determined the device is substantialy marketed in int referenced above and have ustemmed the actives marketed in interstate for use stated in the encrosure) to regary manation to the Medical Device Ameralments, or to commerce prof to May 28, 1970, the cidemic and of the provisions of the Federal Food, Drug, devices that have been reciassified in accordance with the provisions of the Act. The and Cosmetic Act (Act) that do not require apper of the general controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject equirements for annual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the necessor squals would the sugainst misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) and class affecting your device , an be found in Title 21 ,
additional controls. Existing major regulations , 2005 , also supplish fu additional controls. Existing major regulations and to 195. In addition, FDA may publish further
Code of Federal Regulations (CFR), Parts 800 to 195. In and 195 Couc of I ederal regaration your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a determination and your corred by other Federal agencies: You must or any Federal statutes and regulances and including, but not limited to: registing (21)
comply with all the Act's requirements, and act and section (reporting (reporting of comply with an the Act s requirements, theracing, our november of the reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse cromby (21 cegulation (21 CFR Part 820). This letter requirents as set form in the quality of evice as described in your Section 510(k) premaket will anow you to begin marketing your as not equivalence of your device to a legally marketed notification. The FDA imanig of subbantial organ 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 II you uesne specific advice for your covice earonstic Device Evaluation and Safety at (301) 796-007), promote 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
under the MDA regulation (21 Of Ferrare 60) personal of 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 Tou may 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,
Janine M. Morris
Acting 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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# SIEMENS
Traditional 510(k) Submission: MAGNETOM Spectra 3T System
# Section 4 Indications for Use Statement
510(k) Number (if known)
MAGNETOM Spectra Device Names:
## Indications for Use:
The MAGNETOM Spectra is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays cross socional images, are function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be other priysiour paramotions on the region of interest, contrast agents may be used. produce. Boponaing spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Spectra may also be used for imaging during interventional The MAGNETOm opeona with MR compatible devices such as inroom display and MR-safe biopsy needles.
× Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OVID)
.A.D.N.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K12160
Page 1 of 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.
