510(k) · Cleared
Recalled · Class I · 2025MAGNETOM Avantofit, MAGNETOM Skyrafit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Nov 22, 2016 after a 116-day review. The FDA summary names no predicate by number. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Nov 22, 2016
- Review
- 116 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1 (1 Class I)
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK162102 MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK173592 MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit…Siemens Medical Solutions USA, Inc. · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK182299 MAGNETOM AeraSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK190757 MAGNETOM Avanto FitSiemens Medical Solution USA, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK190138 MAGNETOM AeraSiemens Medical Solutions USA, Inc. · 2019
Class I recalls in this family
- K173592 MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM…cites it directly · 2018
Most influential descendants
Showing 4 of 4 · See all- K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · cites it directly3descendants
- K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on1descendant
- K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc. · 2019 · 2 generations on0descendants
- K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K162102 | MAGNETOM Avantofit, MAGNETOM Skyrafit | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| +1 | K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2018 | Class I |
| +2 | K182299 | MAGNETOM Aera | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K190757 | MAGNETOM Avanto Fit | Siemens Medical Solution USA, Inc. | 2019 | — |
| +3 | K190138 | MAGNETOM Aera | Siemens Medical Solutions USA, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 1 |
| 2019 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit Class I | 2018 | 3 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class I | Z-2661-2025 | Under Investigation by firm | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K173592 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The MAGNETOM systems [MAGNETOM Avantofit, MAGNETOM Skyrafit] are 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…
Read the full statement (123 words)
The MAGNETOM systems [MAGNETOM Avantofit, MAGNETOM Skyrafit] are 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 systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162102 · printed Nov 3, 2026
Cite this page
510(k) Report. “K162102: MAGNETOM Avantofit, MAGNETOM Skyrafit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K162102
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026