510(k) · Cleared
ClearedRthawk, Rthawk, or Heartvista Workstation with Rthawk
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 Jun 25, 2014 as substantially equivalent to K041476 (Ge Medical Systems, LLC, 2004) after a 189-day review. Its family tree reaches back 4 generations to 1996. 4 of the 17 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Jun 25, 2014
- Review
- 189 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962061 (1996). 10 ancestors in all. 6 later devices descend from it, 1 citing it directly. 4 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK962061 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1996 · Recalled
- 3 generations backK012200 1.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · Recalled (Class I)
- 2 generations backK013636 Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · Recalled (Class I)
- 1 generation backK041476 GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · Recalled (Class I)
- This deviceK133848 Rthawk, Rthawk, or Heartvista Workstation with RthawkHeartvista, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK142997 RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK153740 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK170090 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2017
- Descendant · 4 generations on · 2 of its ownK183274 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2019
- Descendant · 5 generations on · 1 of its ownK212233 RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…direct predicate · 2004
- K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…2 generations back · 2003
- K013636 Signa Infinity MR System with Excite Technology2 generations back · 2002
- K012200 1.5T Infinity Twinspeed MR System3 generations back · 2001
Most influential descendants
Showing 5 of 6 · See all- K142997RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc. · 2014 · cites it directly5descendants
- K153740RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2016 · 2 generations on4descendants
- K170090RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2017 · 3 generations on3descendants
- K183274RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2019 · 4 generations on2descendants
- K212233RTHawk, HeartVista Cardiac PackageHeartvista, Inc. · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962061 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1996 | 2 |
| −3 | K012200 | 1.5T Infinity Twinspeed MR System | GE Medical Systems | 2001 | Class I |
| −2 | K013636 | Signa Infinity MR System with Excite Technology | GE Medical Systems | 2002 | Class I |
| −1 | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System | Ge Medical Systems, LLC | 2004 | Class I |
| 0 (this device) | K133848 | Rthawk, Rthawk, or Heartvista Workstation with Rthawk | Heartvista, Inc. | 2014 | — |
| +1 | K142997 | RTHawk, HeartVista Workstation with RTHawk | Heartvista, Inc. | 2014 | — |
| +2 | K153740 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2016 | — |
| +3 | K170090 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2017 | — |
| +4 | K183274 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2019 | — |
| +5 | K212233 | RTHawk, HeartVista Cardiac Package | Heartvista, Inc. | 2021 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K041476 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemSummary page 1…51()#Device 510(k) Sponsor 510(k) Clearance 10(k)Date K041 476 GE Signa Excite 1.5T and 31OT MR Systems GE Healthcare 6/11/2004 7.0 Device Description… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142997 | RTHawk, HeartVista Workstation with RTHawk | 2014 | 5 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 6 of the 10 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K142997 (Heartvista, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K041476.
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. 2014, 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?
The HeartVista Workstation with the RTHawk application software is an accessory to I.5T and 3.OT whole-body magnetic resonance diagnostic devices (MRDD or.MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-time and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR)…
Read the full statement (183 words)
The HeartVista Workstation with the RTHawk application software is an accessory to I.5T and 3.OT whole-body magnetic resonance diagnostic devices (MRDD or.MR). The HeartVista Workstation with the RTHawk application software is intended to operate alongside, and in parallel with, the existing MR console to acquire real-time and accelerated images. The HeartVista Workstation with the RTHawk application software is indicated for Cardiovascular MR (CMR) applications.
The HeartVista Workstation with the RTI-awk application software 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 (TI), 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.
The HeartVista Workstation with the RTHawk application software is intended for use as an accessory to the following OEM, MRI system, and software release versions:
*GE Healthcare (GEHC) Signa H-Dxt 1.5T. 3.OT. Software versions 15 and 16.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133848: Rthawk, Rthawk, or Heartvista Workstation with Rthawk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133848
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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