510(k) · Cleared
ClearedMri Patient Positioning Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 14, 2010 as substantially equivalent to K950866 (Medtec, Inc., 1995) and 3 other predicates after a 161-day review. Its family tree reaches back 3 generations to 1991. 14 later devices descend from it.
- Decided
- May 14, 2010
- Review
- 161 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K905007 (1991). 14 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
- 2 generations backK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
- 1 generation backK060737 Sinmed Positioning DevicesSinmed BV · 2006
- This deviceK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- Descendant · cites it directly · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- Descendant · 2 generations on · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015
- Descendant · 2 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- Descendant · 3 generations on · 2 of its ownK212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning…Macromedics BV · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · cites it directly13descendants
- K142420Patient Positioning DevicesMacromedics BV · 2015 · 2 generations on7descendants
- K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 2 generations on5descendants
- K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 3 generations on3descendants
- K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905007 | Standard Breast Boards; Deluxe Breast Board | Bionix Development Corp. | 1991 | — |
| −2 | K030051 | Versaboard, Model 7040 | Bionix Development Corp. | 2003 | — |
| −1 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| 0 (this device) | K093738 | Mri Patient Positioning Devices | Medtec, Inc. | 2010 | — |
| +1 | K111340 | Head and Neck Immobilization System, Body Immobilization System | Medtec, Inc. | 2011 | — |
| +2 | K142420 | Patient Positioning Devices | Macromedics BV | 2015 | — |
| +2 | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
| +3 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body… | Medtec, Inc. D/B/A Civco Medical Solutions | 2016 | — |
| +3 | K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)… | Macromedics BV | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K950866 | Hip Fixation SystemSummary page 1…lproducts cleared for use in an MRI environment. Predicate Devices: Hip and Pelvic Immobilization System: Pelvic Thermoplastics, Pelvic Vac-Lok, Pelvic Board • K950866 -MEDTEC ne, Hip Fix, Hip and Pelvic Fixation * K080072 -CIVCO Medical Solutions, MRI Patient Positioning Devices… | 1995 |
| * | K080072 | Mri Patient Positioning DevicesSummary page 1…Hip and Pelvic Immobilization System: Pelvic Thermoplastics, Pelvic Vac-Lok, Pelvic Board • K950866 -MEDTEC ne, Hip Fix, Hip and Pelvic Fixation * K080072 -CIVCO Medical Solutions, MRI Patient Positioning Devices Breast and Thorax Immobilization System: Belly Board, Arm Positioner… | 2008 |
| * | K060737 | Sinmed Positioning DevicesSummary page 1…Pelvic Fixation * K080072 -CIVCO Medical Solutions, MRI Patient Positioning Devices Breast and Thorax Immobilization System: Belly Board, Arm Positioner * K060737 - SINMED Positioning Devices * K080072 - CIVCO Medical Solutions, MRI Patient Positioning Devices Lower Extremity Immobiliz… | 2006 |
| * | K973842 | Carbon Fiber Conformal Couch TopSummary page 1…ical Solutions, MRI Patient Positioning Devices Lower Extremity Immobilization System: Knee Positioner, Foot Positioner * K060737 -SINMED Positioning Devices a K973842 -MEDTEC nc, Carbon Fiber Conformal]Couch Top a K080072 -CIVCO Medical Solutions, MRI Patient Positioning Devices Page 6 of… | 1997 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111340 | Head and Neck Immobilization System, Body Immobilization System | 2011 | 13 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K111340 (Medtec, Inc., 2011) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K950866.
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?
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093738: Mri Patient Positioning Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093738
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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