510(k) · Cleared
ClearedRestgrid Package/Gyroscan NT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 29, 1998 as substantially equivalent to K980645 (Philips Medical Systems North America, Inc., 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Oct 29, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900889 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK900889 Magnetic Resonance Diagnostic Device AccessoriesSiemens Medical Solutions USA, Inc. · 1990
- 1 generation backK973799 Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSiemens Medical Solutions USA, Inc. · 1998
- This deviceK982834 Restgrid Package/Gyroscan NTPhilips Medical Systems North America, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900889 | Magnetic Resonance Diagnostic Device Accessories | Siemens Medical Solutions USA, Inc. | 1990 | — |
| −1 | K973799 | Cardiac Tagging Techniques/Magnetom Vision and Magnetom Impact | Siemens Medical Solutions USA, Inc. | 1998 | — |
| 0 (this device) | K982834 | Restgrid Package/Gyroscan NT | Philips Medical Systems North America, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K980645 | Philips Gyroscan NT Release 6 SeriesSummary page 2…uivalence ) , Philips believes the RestGrid Software Package to be substantially equivalent to saturation techniques applied in commercially available RestSlabs (FDA re.K980645) and to Siemens Cardiac Tagging (FDA re.K973799). ~—— ERVIC o s 15.¢, N (RIALTY o ., C DEPARTMENT OF HEALTH &… | 1998 |
| * | K973799 | Cardiac Tagging Techniques/Magnetom Vision and Magnetom ImpactSummary page 1…raft standards are used. RestGrid/ Tagging studies / SPAMM / CSPAMM - RestSlab technique Gyroscan NT (ref.K.980645) - Cardiac Tagging Techniques / Magnetom Vision (ref.K973799). RestGrid is a software option available for the Gyrosc\afi"—NT platforms: ACS-NT, T10-NT, T5-NT and the Gyroscan-CV. RestGrid… | 1998 |
| † | K963990 | Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series | 1997 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K980645.
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 RestGrid is a software option to the Philips GYROSCAN NT and GYROSCAN CV systems. This option is used to evaluate regional heart wall motion in both the left and right side of the heart and blood flow in a non-invasive study. The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or…
Read the full statement (113 words)
The RestGrid is a software option to the Philips GYROSCAN NT and GYROSCAN CV systems.
This option is used to evaluate regional heart wall motion in both the left and right side of the heart and blood flow in a non-invasive study.
The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 3'p metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.
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/K982834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982834: Restgrid Package/Gyroscan NT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982834
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