510(k) · Cleared
Recalled · 2008Philips Digital Imaging Option Release 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Oct 30, 2002 as substantially equivalent to K920793 (Philips Medical Systems, Inc., 1992) after a 15-day review. Its family tree reaches back 1 generation to 1992. It has been recalled once.
- Decided
- Oct 30, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920793 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920793 Philips Dsi System Release 3.2Philips Medical Systems, Inc. · 1992 · Recalled
- This deviceK023440 Philips Digital Imaging Option Release 1Philips Medical Systems · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920793 | Philips Dsi System Release 3.2 | Philips Medical Systems, Inc. | 1992 | 2 |
| 0 (this device) | K023440 | Philips Digital Imaging Option Release 1 | Philips Medical Systems | 2002 | — |
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 |
|---|---|---|---|
| * | K920793 | Philips Dsi System Release 3.2Summary page 1…the Philips DSI, release 3.2, manufactured by Philips Medical Systems. The Philips DSI, release 3.2 received a 51O(k) substantially equivalent determination in K920793 on July 17, 1992. Device description: The Digital Imaging is an option to the RF-Diagnost Eleva system family, compri… | 1992 |
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 |
|---|---|---|---|---|
| Jan 4, 2008 | Not classified | Z-2406-2010 | Other | Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Digital Imaging option release 1 is intended to assist physicians for diagnostic purposes and is required for interventional procedures, providing digital functionality as Last Image Hold, Digital Subtraction and contains a user interface for viewing, reviewing and processing digital images. The Digital Imaging option release 1 includes the following features, such as : 1. Providing Digital Acquisition or Fluoroscopy for Philips RF systems. 2.…
Read the full statement (101 words)
The Digital Imaging option release 1 is intended to assist physicians for diagnostic
purposes and is required for interventional procedures, providing digital functionality
as Last Image Hold, Digital Subtraction and contains a user interface for viewing,
reviewing and processing digital images. The Digital Imaging option release 1
includes the following features, such as :
1. Providing Digital Acquisition or Fluoroscopy for Philips RF systems.
2. Diagnostic andor lnterventionalapplications.
3. Live subtracted acquisition and fluoroscopy for vascular applications.
4. Single or multiple images can be acquired and reviewed.
5. Sending digital images to printer, external workstations for post processing and
reconstructions, PACS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023440: Philips Digital Imaging Option Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023440
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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