510(k) · Cleared
ClearedLodox, Model Baseline
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lodox Systems (Pty), Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 6, 2002 as substantially equivalent to K884671 (Elscint, Inc., 1989) and 1 other predicate after a 245-day review. Its family tree reaches back 1 generation to 1989. 8 later devices descend from it.
- Decided
- Aug 6, 2002
- Review
- 245 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884671 (1989). 2 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK884671 Exel 2400 and 2400 Elite CT ScannersElscint, Inc. · 1989
- This deviceK013999 Lodox, Model BaselineLodox Systems (Pty), Ltd. · 2002
- Descendant · cites it directly · 7 of its ownK071546 EOSBiospace Med · 2007 · Recalled
- Descendant · 2 generations on · 6 of its ownK120721 EOSEos Imaging · 2012
- Descendant · 2 generations on · 5 of its ownK123740 EOSEos Imaging · 2013 · Recalled
- Descendant · 3 generations on · 4 of its ownK142773 EOS SystemEos Imaging · 2015
- Descendant · 4 generations on · 3 of its ownK152788 EOS SystemEos Imaging · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K071546EOSBiospace Med · 2007 · cites it directly7descendants
- K120721EOSEos Imaging · 2012 · 2 generations on6descendants
- K123740EOSEos Imaging · 2013 · 2 generations on5descendants
- K142773EOS SystemEos Imaging · 2015 · 3 generations on4descendants
- K152788EOS SystemEos Imaging · 2015 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884671 | Exel 2400 and 2400 Elite CT Scanners | Elscint, Inc. | 1989 | — |
| 0 (this device) | K013999 | Lodox, Model Baseline | Lodox Systems (Pty), Ltd. | 2002 | — |
| +1 | K071546 | EOS | Biospace Med | 2007 | 1 |
| +2 | K120721 | EOS | Eos Imaging | 2012 | — |
| +2 | K123740 | EOS | Eos Imaging | 2013 | 1 |
| +3 | K142773 | EOS System | Eos Imaging | 2015 | — |
| +4 | K152788 | EOS System | Eos Imaging | 2015 | — |
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 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K884671 | Exel 2400 and 2400 Elite CT ScannersSummary page 2…ct Code: SOMQB 5.4 Identification of Predicate Device(s) [21CFR807.92(a)(3)] Equivalency is based on the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (… | 1989 |
| * | K950883 | Polydoros SX 65 and 80Summary page 2…on of Predicate Device(s) [21CFR807.92(a)(3)] Equivalency is based on the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (21CFR892.1840). 5.5 Description of the Device [… | 1995 |
| * | — | bucky (x-ray film holder) using conventional radiographic film Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071546 | EOS | 2007 | 7 |
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.
- Of its descendants, K071546 (Biospace Med, 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mrn, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013999: Lodox, Model Baseline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013999
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026