510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Prestilix 1694 D Image Intensified Fluorosccopic

K924310510(k) TraditionalCleared Jan 21, 1993148-day reviewClass II21 CFR 892.2050Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Medical Systems · LLZ System, Image Processing, Radiological

Cleared on Jan 21, 1993 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 133 later devices descend from it. It has been recalled once.

Decided
Jan 21, 1993
Review
148 days
Class
Class II
Product code
LLZ
Recalls
1
Predicates
0

133 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 1 descendant cleared1999: 1 descendant cleared2004: 1 descendant cleared2007: 2 descendants cleared2005: 2 descendants cleared2006: 1 descendant cleared2011: 4 descendants cleared2008: 3 descendants cleared2010: 5 descendants cleared2015: 5 descendants cleared2013: 3 descendants cleared2009: 1 descendant cleared2018: 9 descendants cleared2014: 5 descendants cleared2022: 8 descendants cleared2019: 11 descendants cleared2012: 4 descendants cleared2017: 3 descendants cleared2016: 7 descendants cleared2024: 6 descendants cleared2025: 11 descendants cleared2021: 11 descendants cleared2020: 13 descendants cleared2023: 7 descendants cleared2026: 8 descendants cleared1990200020102020
  1. This deviceK924310 Prestilix 1694 D Image Intensified FluorosccopicGE Medical Systems · 1993
  2. Descendant · cites it directly · 132 of its ownK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
  3. Descendant · 2 generations on · 131 of its ownK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
  4. Descendant · 3 generations on · 130 of its ownK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
  5. Descendant · 4 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
  6. Descendant · 4 generations on · 49 of its ownK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled

Showing 5 of 133 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11999: 12004: 12005: 22006: 12007: 22008: 32009: 12010: 52011: 42012: 42013: 32014: 52015: 52016: 72017: 32018: 92019: 112020: 132021: 112022: 82023: 72024: 62025: 112026: 8
1996high 13 (2020) · low 0 (1998)2026

Most influential descendants

Showing 5 of 133 · See all
  • K960266Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · cites it directly132descendants
  • K970734Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 1997 · 2 generations on131descendants
  • K992660Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · 3 generations on130descendants
  • K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on78descendants
  • K040675Axiom Artis USiemens Medical Systems, Inc. · 2004 · 4 generations on49descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924310Prestilix 1694 D Image Intensified FluorosccopicGE Medical Systems1993—
+1K960266Siregraph CFSiemens Medical Solutions USA, Inc.19963
+2K970734Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray SystemsSiemens Medical Solutions USA, Inc.1997—
+3K992660Urf Digital - OTSiemens Medical Solutions USA, Inc.19994
+4K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.200720
+4K040675Axiom Artis USiemens Medical Systems, Inc.20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199910
200410
200520
200610
200720
200830
200910
201050
201140
201240
201330
201450
201550
201670
201730
201890
2019110
2020130
2021110
202280
202370
202460
2025110
202680
FIG. 1 — Lineage of K924310, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (133)

See all 133

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960266Siregraph CFSiemens Medical Solutions USA, Inc.1996132

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2016Class IIZ-0914-2017Nonconforming Material/ComponentGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K960266 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 132 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

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https://510kreport.com/device/K924310 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924310: Prestilix 1694 D Image Intensified Fluorosccopic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924310

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026