510(k) · Cleared
ClearedRaypax System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raypax, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 19, 2008 as substantially equivalent to K043415 (Ge Medical Systems Information Technologies, 2005) after a 73-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Sep 19, 2008
- Review
- 73 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913770 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- This deviceK081948 Raypax SystemRaypax, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| 0 (this device) | K081948 | Raypax System | Raypax, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 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 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 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K043415 | Centricity Pacs SystemSummary page 1…Regulation Number: 892.2050 Device Class: 2 1.3 Predicative Device Information (807 92(a)(3)) 510(k) Number K043415 Device Name CENTRICITY PACS SYSTEM ApplicantMEDICAL SYSTEMS INFORMATION… | 2005 |
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 17 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 10 other devices also cite its predicate K043415.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The RAYPAX System is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images acquired from devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound, (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Film Scanners, and any other DICOM…
Read the full statement (248 words)
The RAYPAX System is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images acquired from devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound, (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Film Scanners, and any other DICOM supporting devices.
The clients of RAYPAX System are intended for diagnostic and analysis tool by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. QCW(Quality control Workstation) is intended for technicians to verify exams. DW(Diagnostic Workstation) and RW(Review Workstation) is intended for radiologists to perform a diagnostic analysis of the exams and WCC(Web Client Component) is intended for the clinical review of physicians. Net Point and Lite are intended to acquire exams from remote facilities through the Internet. Net, Exp and Web client versions are intended for a remote access to the images through the Internet.
For the digital mammography images, to be viewed for primary interpretation, images must be acquired from an FDA approved Mammography device for primary interpretation and viewed on a display system with at least 5 Mega Pixel of resolution and has been cleared by the FDA for diagnosis of digital mammography images. Furthermore, the Mammography device must be able to provide, to the RAYPAX System, a viewable DICOM 'for presentation' mammography image. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081948 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081948: Raypax System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081948
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