510(k) · Cleared
Recalled · Class II · 2021Liebel-Flarsheim Direct Digital Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liebel-Flarsheim · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 11, 2012 as substantially equivalent to K943581 (Mallinckrodt Group, Inc., 1995) and 2 other predicates after a 19-day review. Its family tree reaches back 9 generations to 1980. It has been recalled 2 times.
- Decided
- Jul 11, 2012
- Review
- 19 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 9 generations to K801623 (1980). 72 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations between
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- This deviceK121838 Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim · 2012
Show all 9 generations
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 7 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 6 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 5 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 4 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
- This deviceK121838 Liebel-Flarsheim Direct Digital Imaging SystemLiebel-Flarsheim · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −8 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −7 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −6 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −5 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −4 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −1 | K101491 | Uroskop Omnia | Siemens Medical Solutions USA, Inc. | 2010 | 12 |
| 0 (this device) | K121838 | Liebel-Flarsheim Direct Digital Imaging System | Liebel-Flarsheim | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 13 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2004 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 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? (3)
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 |
|---|---|---|---|
| * | K943581 | Hydradjust IV Urological TableSummary page 1…n: 21 CFR 892.1650 Device Class: Class 11 Product Code: MQB Predicate Devices: Hydra Vision Urological X-Ray System (K943581I) UROSKOP Omnia (K101491) Nexus DRF Digital X-ray Imaging System (K103416) Device Description: The Liebel-Flarsheimn Direct Dig… | 1995 |
| * | K101491 | Uroskop OmniaSummary page 1…1650 Device Class: Class 11 Product Code: MQB Predicate Devices: Hydra Vision Urological X-Ray System (K943581I) UROSKOP Omnia (K101491) Nexus DRF Digital X-ray Imaging System (K103416) Device Description: The Liebel-Flarsheimn Direct Digital Imaging System is a… | 2010 |
| * | K103416 | Nexus DRF Digital X-Ray Imaging SystemSummary page 1…Product Code: MQB Predicate Devices: Hydra Vision Urological X-Ray System (K943581I) UROSKOP Omnia (K101491) Nexus DRF Digital X-ray Imaging System (K103416) Device Description: The Liebel-Flarsheimn Direct Digital Imaging System is a radiographic and fluoroscopy examination' table w… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2021 | Class II | Z-1992-2021 | Radiation Control for Health and Safety Act | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the… |
| Feb 27, 2017 | Class II | Z-2834-2018 | Radiation Control for Health and Safety Act | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 25 of the 72 ancestors have a recall of any class.
- 2 other devices also cite its predicate K943581.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The Liebel-Flarsheim Direct Digital Imaging System is a solid state detector X-ray system that facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/surgery. The system inky be used for urological, gastroenterological, and gynecological treatment, planning and diagnostic procedures. It is intended to replace fluoroscopic images formerly obtained through image intensifier technology. Not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121838: Liebel-Flarsheim Direct Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121838
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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