510(k) · Cleared
ClearedSnapShot Freeze 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 13, 2019 as substantially equivalent to K120910 (GE Medical Systems SCS, 2012) after a 90-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Feb 13, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000315 (2000). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- 4 generations backK013422 Cardiq FunctionGE Medical Systems · 2001
- 3 generations backK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- 2 generations backK073138 Cardiq Express Version 2.0GE Medical Systems · 2008
- 1 generation backK120910 Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 RevealGE Medical Systems SCS · 2012
- This deviceK183161 SnapShot Freeze 2Ge Medical Systems, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| −4 | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| −3 | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| −2 | K073138 | Cardiq Express Version 2.0 | GE Medical Systems | 2008 | — |
| −1 | K120910 | Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 Reveal | GE Medical Systems SCS | 2012 | — |
| 0 (this device) | K183161 | SnapShot Freeze 2 | Ge Medical Systems, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K120910 | Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 RevealSummary page 6…CardIQ Xpress 2.0 with SnopShot Freeze Option Manufacturer GE Medical System SCS (d.b.a GE Healthcare) 510(k) number K120910 cleared on June 18, 2012 Regulation number 21 CFR 892.1750 Computed tomography x-ray system / /product Code… | 2012 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K120910.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
SnapShot Freeze 2 is designed for use with gated cardiac acquisitions to reduce cardiac induced motion artifacts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183161 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183161: SnapShot Freeze 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183161
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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