510(k) · Cleared
ClearedJoint Motion Device Package PN 1032,Kneel Cervical PN 1026, Lumbar 1027, Wrist 1028, Ankle 1029, Shoulder 1030, Hip 1031
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chamco, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 22, 1998 as substantially equivalent to K953918 (Hitachi Medical Systems America, Inc., 1995) after a 77-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Oct 22, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953918 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953918 Magnetic Resonance Diagnostic DeviceHitachi Medical Systems America, Inc. · 1995
- This deviceK982761 Joint Motion Device Package PN 1032,Kneel Cervical PN 1026, Lumbar…Chamco, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953918 | Magnetic Resonance Diagnostic Device | Hitachi Medical Systems America, Inc. | 1995 | — |
| 0 (this device) | K982761 | Joint Motion Device Package PN 1032,Kneel Cervical PN 1026, Lumbar 1027, Wrist… | Chamco, Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K953918 | Magnetic Resonance Diagnostic DeviceSummary page 2…2.7.8 Joint Motion Device Package* P/N 1032 2.7.9 Storage Cabinet P/N 1033 *Includes all devices plus the storage cabinet 3.0 Predicate Device 3.1 32 33 3.4 3.5 3.6 K953918 Hitachi Medical Systems America, Inc. Joint Motion Devices Manufactured by CHAMCO, Inc. Sept. 12, 1995 Regulatory Class 11 21 C… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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.
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 Joint Motion Devices are an accessory to MRI diagnostic devices, including the Hitachi AIRIS™, Siemens Magnatom™, Toshiba OPART™, Picker Outlook™, Fonar, and GE Medical Systems Open MRI systems. In addition, the devices may be used in any MRI system where the physical limits of the bore size is not a constraint. The devices are built from plastics and nonferromagnetic materials, and hold patients securely during MRI imaging sequences. The devices…
Read the full statement (253 words)
The Joint Motion Devices are an accessory to MRI diagnostic devices, including the Hitachi AIRIS™, Siemens Magnatom™, Toshiba OPART™, Picker Outlook™, Fonar, and GE Medical Systems Open MRI systems. In addition, the devices may be used in any MRI system where the physical limits of the bore size is not a constraint.
The devices are built from plastics and nonferromagnetic materials, and hold patients securely during MRI imaging sequences. The devices also constrain joint motion to one of several user-designated planes of rotation, dependant upon the joint to be imaged, and emulate the natural motion of the joint.
The Joint Motion Devices increase the clinical utility of MRI systems to provide high quality, repeatable imaging and constraint for the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies to enable fixed position imaging, and kinematic (incremental stepped) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, and dynamic (continuous) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder joint anatomies.
The devices will enable the physician to evaluate the anatomy of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, in a static mode as well as to evaluate the dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such functional interaction may be useful in diagnosis.
The intended patients are primarily drawn from a pool of those subjects undergoing diagnostic evaluation by physicians who are skilled in diagnosis and treatment of the disease processes under consideration.
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/K982761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982761: Joint Motion Device Package PN 1032,Kneel Cervical PN 1026, Lumbar 1027, Wrist 1028, Ankle 1029, Shoulder 1030, Hip 1031.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982761
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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