510(k) Report

510(k) · Cleared

Recalled · 2005

Adc QS/Ipd Workstation

K010571510(k) SpecialCleared Mar 28, 200130-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

Agfa Corp. · LLZ System, Image Processing, Radiological

Cleared on Mar 28, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.

Decided
Mar 28, 2001
Review
30 days
Class
Class II
Product code
LLZ
Recalls
1
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK010571 Adc QS/Ipd WorkstationAgfa Corp. · 2001
  2. Descendant · cites it directly · 6 of its ownK063421 DX-SIAgfa Corp. · 2006
  3. Descendant · 2 generations on · 5 of its ownK072010 Quantum Direx SystemQuantum Medical Imaging, LLC · 2007
  4. Descendant · 3 generations on · 4 of its ownK080905 Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
  5. Descendant · 4 generations on · 3 of its ownK193574 Q-Rad SystemCarestream Health, Inc. · 2020
  6. Descendant · 5 generations on · 2 of its ownK201373 DRX-CompassCarestream Health, Inc. · 2020 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12020: 22023: 12026: 1
2006high 2 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all
  • K063421DX-SIAgfa Corp. · 2006 · cites it directly6descendants
  • K072010Quantum Direx SystemQuantum Medical Imaging, LLC · 2007 · 2 generations on5descendants
  • K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008 · 3 generations on4descendants
  • K193574Q-Rad SystemCarestream Health, Inc. · 2020 · 4 generations on3descendants
  • K201373DRX-CompassCarestream Health, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010571Adc QS/Ipd WorkstationAgfa Corp.2001—
+1K063421DX-SIAgfa Corp.2006—
+2K072010Quantum Direx SystemQuantum Medical Imaging, LLC2007—
+3K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC2008—
+4K193574Q-Rad SystemCarestream Health, Inc.2020—
+5K201373DRX-CompassCarestream Health, Inc.20201

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
202020
202310
202610
FIG. 1 — Lineage of K010571, 2001–2026Source: 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
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (7)

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

NumberDeviceApplicantDecidedDescendants
K063421DX-SIAgfa Corp.20066

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 18, 2005Not classifiedZ-0353-06OtherUsers of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K063421 (Agfa Corp., 2006) has gone furthest, with 6 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—

More from Agfa Corp.

19 FDA decisions under this applicant name. See the company

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  • K050810Agfa CR50.0Agfa Corp. · 20052 recalls
  • K042779Radiotherapy Solution Based on CRAgfa Corp. · 2004

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The LLZ category page

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https://510kreport.com/device/K010571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010571: Adc QS/Ipd Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010571

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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