510(k) · Cleared
Recalled · Class II · 2016Philips Computed Radiography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 18, 1996 as substantially equivalent to K915237 (Philips Medical Systems, Inc., 1992) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1992. 18 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 18, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915237 (1992). 2 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915237 Philips PCR-Ace SystemPhilips Medical Systems, Inc. · 1992
- This deviceK964124 Philips Computed RadiographyPhilips Medical Systems, Inc. · 1996
- Descendant · cites it directly · 16 of its ownK063781 Philips XD-S Direct Radiography Workstation/PackagePhilips Medical Systems North America Co. · 2007 · Recalled
- Descendant · 2 generations on · 15 of its ownK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- Descendant · 3 generations on · 6 of its ownK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK203188 ADDH&abyz Co., Ltd. · 2021
- Descendant · 4 generations on · 3 of its ownK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K063781Philips XD-S Direct Radiography Workstation/PackagePhilips Medical Systems North America Co. · 2007 · cites it directly16descendants
- K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014 · 2 generations on15descendants
- K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · 3 generations on6descendants
- K203188ADDH&abyz Co., Ltd. · 2021 · 3 generations on3descendants
- K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915237 | Philips PCR-Ace System | Philips Medical Systems, Inc. | 1992 | — |
| 0 (this device) | K964124 | Philips Computed Radiography | Philips Medical Systems, Inc. | 1996 | — |
| +1 | K063781 | Philips XD-S Direct Radiography Workstation/Package | Philips Medical Systems North America Co. | 2007 | 1 |
| +2 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| +3 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
| +3 | K203188 | ADD | H&abyz Co., Ltd. | 2021 | — |
| +4 | K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K915237 | Philips PCR-Ace SystemSummary page 2…the technological characteristics of the PCR 5.2 system to those of the PCR ACe system. The PCR ACe system has been granted a 510(k) clearance. Refer to accession number K915237. Also, the image processing algorithm called Dynamic Range Reconstruction (DRR) used with PCR 5.2 is considered substantially equ… | 1992 |
| * | K951373 | Fuji Computed Radiography System FCR9000HQ, FCR9501HQSummary page 1…number K896050A. The AC3 has been granted a 510(k) clearance. Refer to accession number K944046. The 9000 has been granted a 510(k) clearance. Refer to accession number K951373. Philips Medical Systems North America Company 710 Bridgeport Avenue Shelton, CT 06484-4708 Tel: (203) 926-7674 Fax: {203) 929-… | 1995 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2016 | Class II | Z-2681-2016 | Component design/selection | A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing. |
| Jul 27, 2011 | Not classified | Z-3205-2011 | Software design | The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis |
| Dec 23, 2008 | Not classified | Z-1019-2011 | Software design | There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K063781 (Philips Medical Systems North America Co., 2007) has gone furthest, with 16 descendants of its own.
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 PCR 5.2 System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The Philips PCR system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964124: Philips Computed Radiography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964124
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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