510(k) · Cleared
ClearedAltaire Interventional MR Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 24, 2006 as substantially equivalent to K984280 (Hitachi Medical Systems America, Inc., 1999) after a 57-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jan 24, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955389 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK955389 MR Guided Procedures Package/Magnetom Open SystemSiemens Medical Solutions USA, Inc. · 1996
- 1 generation backK984280 Airis II Magnetic Resonance Diagnostic Device,Interventional MR…Hitachi Medical Systems America, Inc. · 1999
- This deviceK053309 Altaire Interventional MR PackageHitachi Medical Systems America, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955389 | MR Guided Procedures Package/Magnetom Open System | Siemens Medical Solutions USA, Inc. | 1996 | — |
| −1 | K984280 | Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package | Hitachi Medical Systems America, Inc. | 1999 | — |
| 0 (this device) | K053309 | Altaire Interventional MR Package | Hitachi Medical Systems America, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K984280 | Airis II Magnetic Resonance Diagnostic Device,Interventional MR PackageSummary page 1…em Classification Name Magnetic Resonance D)iaonostic Dce ice Predicate I)ev ice H1itachi AlRIS I! Magnetic Resonance I)iTgiistic I)exice lntcrxeniional NIR Package (K984280) , 2OI)5 ? t ii Ililachi… | 1999 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053309: Altaire Interventional MR Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053309
Report an extraction error
Are you the manufacturer?
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