510(k) · Cleared
Clearedi_Space 1.5T Superconducting Magnetic Resonance Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Division,Beijing Wandong Medical Technology Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 29, 2021 as substantially equivalent to K052172 (Hitachi Medical Systems America, Inc., 2005) after a 493-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Jan 29, 2021
- Review
- 493 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K955249 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 5 generations backK973450 Sensor PadInventive Products, Inc. · 1997
- 4 generations backK991469 Aware PadAac Consulting Group, Inc. · 1999
- 3 generations backK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- 2 generations backK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- 1 generation backK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- This deviceK192650 i_Space 1.5T Superconducting Magnetic Resonance Imaging SystemMri Division,Beijing Wandong Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK221025 i_ Field 1.5T Superconducting Magnetic Resonance Imaging SystemMri Division,Beijing Wandong Medical Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221025i_ Field 1.5T Superconducting Magnetic Resonance Imaging SystemMri Division,Beijing Wandong Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −5 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| −4 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| −3 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| −2 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| −1 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| 0 (this device) | K192650 | i_Space 1.5T Superconducting Magnetic Resonance Imaging System | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | 2021 | — |
| +1 | K221025 | i_ Field 1.5T Superconducting Magnetic Resonance Imaging System | Mri Division,Beijing Wandong Medical Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K052172 | HHF1 Magnetic Resonance Imaging SystemSummary page 4…onducting Magnetic Resonance Imaging System 2.5 Regulation number: 21 CFR 892.1000 2.6 Review panel: Radiology 3 Identification of Predicate Devices 3.1 510K Number: K052172 3.2 Manufacturer: Hitachi Medical Systems America, Inc. 3.3 Trade Name: HHF1 Magnetic Resonance Imaging System… | 2005 |
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 |
|---|---|---|---|
| K221025 | i_ Field 1.5T Superconducting Magnetic Resonance Imaging System | 2022 | 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 26 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K221025 (Mri Division,Beijing Wandong Medical Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K052172.
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. 2021, 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?
i_ Space 1.5T Superconducting Magnetic Resonance Imaging System is ao imaging device, wh ich is intended 10 provide the physician with physio logical and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR1 System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the bead, body, or extremities. The images produced by the MRI System reflect the spatial distribution…
Read the full statement (113 words)
i_ Space 1.5T Superconducting Magnetic Resonance Imaging System is ao imaging device, wh ich is intended 10 provide
the physician with physio logical and clinical information, obtained non-invasively and without the use of ionizing
radiation. The MR1 System produces transverse, sagittal, coronal, and oblique images that display the internal structure of
the bead, body, or extremities. The images produced by the MRI System reflect the spatial distribution of protons
(hydrogen nuclei) exl1ibi1ing magnetic resonance. TI1e NMR propenies that de1em1ine the image appearance are proton
density, spin- lattice relaxation time (Tl), spin-spin relaxation time (T2) and flow. When interpreted by a traioed-physician,
these images provide infomiation t hat can be useful in diagnosis detemiinatioo.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192650: i_Space 1.5T Superconducting Magnetic Resonance Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192650
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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