510(k) · Cleared
Recalled · Class II · 2014CDP 5000, Media and Distribution Center, Diagnet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cdp, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Nov 8, 2007 as substantially equivalent to K020995 (Efilm Medical, Inc., 2002) after a 20-day review. Its family tree reaches back 5 generations to 1990. It has been recalled 2 times.
- Decided
- Nov 8, 2007
- Review
- 20 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K896095 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 2 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 1 generation backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- This deviceK072960 CDP 5000, Media and Distribution Center, DiagnetCdp, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −4 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −3 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −2 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −1 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| 0 (this device) | K072960 | CDP 5000, Media and Distribution Center, Diagnet | Cdp, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K020995 | Efilm Workstation with ModulesSummary page 1…CS) Classification Name Image Processing system Product Code LLZ - 21 CFR 892.2050 Predicate Device eFilm Medical Inc. eFilm Workstation with Modules, K020995, for image viewing and manipulation. Intended Use… | 2002 |
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 |
|---|---|---|---|---|
| Apr 2, 2014 | Class II | Z-1495-2014 | Software design | Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations |
| Sep 1, 2011 | Not classified | Z-0032-2012 | Software design | Clinical measurements on true size printouts may be inaccurate |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 14 other devices also cite its predicate K020995.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Users of…
Read the full statement (186 words)
The CDP 5000 is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
The CDP 5000 receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources).
Users of CDP 5000 can perform the following tasks:
* Query and retrieve images from the CDP 5000 Archive, using any third party workstation capable of performing DICOM query/retrieve functions.
* Use DIAGNET network viewer to search, retrieve and manipulate patient images.
• Create DICOM compliant portable media (i.e. CD-R) containing: original DICOM images as sent by imaging modality and the DIAGNET viewer application.
Tasks that users of DIAGNET may perform include, but are not limited to: navigation; adjustment of window width and level; image stacking; measurements; inversion; zoom; magnification; rotation, Linked navigation, MPR (Multi-Planar Reformatting).
Typical users of the CDP 5000 and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians, technologist, and others.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072960 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072960: CDP 5000, Media and Distribution Center, Diagnet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072960
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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