510(k) · Cleared
ClearedPica Whole Body Mri System Model TMS-Mri-3500WB-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Time Medical Limited · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Mar 24, 2010 as substantially equivalent to K091580 (Time Medical Limited, 2009) after a 90-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Mar 24, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K073457 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK073457 Mstar MPD4500Xinaomdt Technology Co., Ltd. · 2008
- 1 generation backK091580 Pica Whole Body Mri SystemTime Medical Limited · 2009
- This deviceK093984 Pica Whole Body Mri System Model TMS-Mri-3500WB-01Time Medical Limited · 2010
- Descendant · cites it directly · 0 of its ownK110942 Pica Whole-Body Mri SystemTime Medical Limited · 2011
Most influential descendants
Showing 1 of 1 · See all- K110942Pica Whole-Body Mri SystemTime Medical Limited · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K073457 | Mstar MPD4500 | Xinaomdt Technology Co., Ltd. | 2008 | — |
| −1 | K091580 | Pica Whole Body Mri System | Time Medical Limited | 2009 | — |
| 0 (this device) | K093984 | Pica Whole Body Mri System Model TMS-Mri-3500WB-01 | Time Medical Limited | 2010 | — |
| +1 | K110942 | Pica Whole-Body Mri System | Time Medical Limited | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 LNH? 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? (1)
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 |
|---|---|---|---|
| * | K091580 | Pica Whole Body Mri SystemSummary page 1…stem. Nuclear Magnetic Resonance Imaging Classification Class 11 / LNH / 892. 1000 Predicate Device: Pica Whole Body MIRI System TMS-MRI-3000WB-01 (1K091580) Intended Use: PICA is indicated for use as magnetic resonance diagnostic devices (MR.DD) that produce… | 2009 |
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 |
|---|---|---|---|
| K110942 | Pica Whole-Body Mri System | 2011 | 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 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110942 (Time Medical Limited, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091580.
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. 2010, 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?
Pica Whole Body MRI System, TMS-MRI-3500WB-01 is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.
It may 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/K093984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093984: Pica Whole Body Mri System Model TMS-Mri-3500WB-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093984
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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