510(k) · Cleared
ClearedSmart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare (Suzhou) Co., Ltd. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Sep 1, 2023 as substantially equivalent to K212864 (Philips Healthcare (Suzhou) Co., Ltd., 2021) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Sep 1, 2023
- Review
- 56 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954190 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK954190 Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc. · 1995
- 4 generations backK093842 1.5T and 3.0T General Purpose Flex CoilsInvivo Corporation · 2010
- 3 generations backK111673 1.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation · 2011
- 2 generations backK120122 Sense MSK S 8CH 1.5TInvivo Corporation · 2012
- 1 generation backK212864 dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2021
- This deviceK232021 Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK260519 Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954190 | Model 580GE-64 Quadrature Abdominal Flex Coil | Medical Advances, Inc. | 1995 | — |
| −4 | K093842 | 1.5T and 3.0T General Purpose Flex Coils | Invivo Corporation | 2010 | — |
| −3 | K111673 | 1.5T and 3T 8-Channel Medium General Purpose Flex Coil | Invivo Corporation | 2011 | — |
| −2 | K120122 | Sense MSK S 8CH 1.5T | Invivo Corporation | 2012 | — |
| −1 | K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2021 | — |
| 0 (this device) | K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2023 | — |
| +1 | K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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.
Planning a device in MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TSummary page 4…S TorsoCardiac 1.5T Device for Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. Smart Fit 510(k) Clearance: K212864 TorsoCardiac Classification Regulation: 21CFR 892.1000 1.5T Classification name:… | 2021 |
| * | K162001 | 1.5T and 3.0T 16 CH GE Shoulder CoilsSummary page 4…1.5T 16 CH GE Shoulder Coils Device for Manufacturer: InVivo Corporation Smart Fit 510(k) Clearance: K162001 Shoulder 1.5T Classification Regulation: 21CFR 892.1000 Classification name:… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260519 | Smart Fit TorsoCardiac 1.5T | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K260519 (Philips Healthcare (Suzhou) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The Smart Fit TorsoCardiac 1.5T coll is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician.
The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232021
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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