510(k) · Cleared
ClearedNeoray DR 2520 Digital Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portavision Medical, LLC · IZL System, X-Ray, Mobile
Cleared on Nov 21, 2008 as substantially equivalent to K043062 (Source-Ray, Inc., 2004) and 1 other predicate after a 38-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Nov 21, 2008
- Review
- 38 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973833 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK973833 Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube…Dynarad Corp. · 1997
- This deviceK083048 Neoray DR 2520 Digital Imaging SystemPortavision Medical, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973833 | Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing… | Dynarad Corp. | 1997 | — |
| 0 (this device) | K083048 | Neoray DR 2520 Digital Imaging System | Portavision Medical, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K043062 | Model SR-130-D Portable Digital X-Ray SystemSummary page 1…Mobile X-Ray System Device classification name: Mobile x-ray system IZL at 21 CFR Part 892.1720 Legally marketed devices K043062 to which the device is Portable Digital X-Ray System Model SR-i 30-D substantially equivalent: SourceRay, Inc.… | 2004 |
| * | K973833 | Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic…Summary page 1…K043062 to which the device is Portable Digital X-Ray System Model SR-i 30-D substantially equivalent: SourceRay, Inc. K973833 NEO Mobile X-Ray System Dynarad Corp. Description of the devic… | 1997 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The NeoRay DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy, it is specifically optimized to operate within the Neonatal environment. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083048: Neoray DR 2520 Digital Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083048
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