510(k) · Cleared
ClearedRTHawk, HeartVista Cardiac Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartvista, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 5, 2021 as substantially equivalent to K183274 (Heartvista, Inc., 2019) after an 81-day review. Its family tree reaches back 9 generations to 1996. 4 of the 17 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Oct 5, 2021
- Review
- 81 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962061 (1996). 15 ancestors in all. 1 later device descends from it, 1 citing it directly. 4 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 5 generations between
- 3 generations backK153740 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2016
- 2 generations backK170090 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2017
- 1 generation backK183274 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2019
- This deviceK212233 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK251029 Vista OS, Vista AI Scan, RTHawkVista AI, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 8 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 7 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 6 generations backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- 5 generations backK133848 Rthawk, Rthawk, or Heartvista Workstation with RthawkHeartvista, Inc. · 2014
- 4 generations backK142997 RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc. · 2014
- 3 generations backK153740 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2016
- 2 generations backK170090 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2017
- 1 generation backK183274 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2019
- This deviceK212233 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2021
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…6 generations back · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…7 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology7 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System8 generations back · 2001
Most influential descendants
Showing 1 of 1 · See all- K251029Vista OS, Vista AI Scan, RTHawkVista AI, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −8 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −7 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −6 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| −5 | K133848 | Rthawk, Rthawk, or Heartvista Workstation with Rthawk | Heartvista, Inc. | 2014 | — |
| −4 | K142997 | RTHawk, HeartVista Workstation with RTHawk | Heartvista, Inc. | 2014 | — |
| −3 | K153740 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2016 | — |
| −2 | K170090 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2017 | — |
| −1 | K183274 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2019 | — |
| 0 (this device) | K212233 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2021 | — |
| +1 | K251029 | Vista OS, Vista AI Scan, RTHawk | Vista AI, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K183274 | RTHawk, HeartVista Cardiac PackageSummary page 5…510(k) Sponsor 510(k) Clearance Date K183274 RTHawk, HeartVista Cardiac Package HeartVista 10/18/2019 7.0 Device Description RTHawk… | 2019 |
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 |
|---|---|---|---|
| K251029 | Vista OS, Vista AI Scan, RTHawk | 2025 | 0 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 15 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K251029 (Vista AI, Inc., 2025) has gone furthest, with 0 descendants of its own.
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?
RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR). It is intended to operate alongside, and in parallel with, the existing MR console to acquire traditional, real-time and accelerated images. The HeartVista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images. RTHawk produces static and dynamic transverse, coronal, sagittal, and…
Read the full statement (171 words)
RTHawk is an accessory to 1.5T and 3.0T whole-body magnetic resonance diagnostic devices (MRDD or MR). It is intended to operate alongside, and in parallel with, the existing MR console to acquire traditional, real-time and accelerated images. The HeartVista Cardiac Package is a collection of RTHawk Apps designed to acquire, reconstruct and display cardiovascular MR (CMR) images.
RTHawk produces static and dynamic transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structures and/or functions of the entire body. The images produced reflect the spatial distribution of nuclei exhibiting magnetic resonance. The magnetic resonance properties that determine image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that may assist in the determination of a diagnosis.
RTHawk is intended for use as an accessory to the following MRI systems:
Manufacturers: GE Healthcare (GEHC), Siemens Healthineers
Field Strength: 1.5T and 3.0T
GE Software Versions: 12, 15, 16, 23, 24, 25, 26
Siemens Software Versions: N4/VE; NX/VA
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/K212233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212233: RTHawk, HeartVista Cardiac Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212233
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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