510(k) · Cleared
Recalled · Class II · 2013Bellyboard, SBRT Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec Inc. Dba Civco Medical Solutions · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jun 8, 2012 as substantially equivalent to K060737 (Sinmed BV, 2006) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1991. It has been recalled 2 times.
- Decided
- Jun 8, 2012
- Review
- 14 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K905007 (1991). 11 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK121545 Bellyboard, SBRT AccessoriesMedtec Inc. Dba Civco Medical Solutions · 2012
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) | K121545 | Bellyboard, SBRT Accessories | Medtec Inc. Dba Civco Medical Solutions | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 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? (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 |
|---|---|---|---|
| * | K060737 | Sinmed Positioning DevicesSummary page 1…ions, claims the proposed devices to be substantially equivalent to the following devices devices previously cleared by the FDA in the following S10(k)s: ¢ Bellyboard o K060737 — Sinmed Immobilization Systems (Head and Shoulder, Lung and Thorax, Pelvis and Lower Extremities, and Posicast) and Sinmed Repov… | 2006 |
| * | K973842 | Carbon Fiber Conformal Couch TopSummary page 1…K060737 — Sinmed Immobilization Systems (Head and Shoulder, Lung and Thorax, Pelvis and Lower Extremities, and Posicast) and Sinmed Repovac Cushions e SBRT Accessories o K973842 - MEDTEC, Inc. Carbon Fiber Conformal Couch Top The predicate devices have been used for many years in radiological and other me… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2013 | Class II | Z-0802-2014 | Device Design | Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. |
| Oct 25, 2013 | Class II | Z-0803-2014 | Device Design | Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K060737.
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. 2012, 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?
civco Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.
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/K121545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121545: Bellyboard, SBRT Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121545
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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