510(k) · Cleared
ClearedAuklet CT Scanner, TSX-003A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 22, 1997 as substantially equivalent to K941745 (Toshiba America Medical Systems, In.C, 1994) after a 69-day review. Its family tree reaches back 1 generation to 1994. 8 later devices descend from it.
- Decided
- Dec 22, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941745 (1994). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK941745 TSX-002A (Xvision) CT ScannerToshiba America Medical Systems, In.C · 1994
- This deviceK973908 Auklet CT Scanner, TSX-003AToshiba America Medical Systems, In.C · 1997
- 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 | K941745 | TSX-002A (Xvision) CT Scanner | Toshiba America Medical Systems, In.C | 1994 | — |
| 0 (this device) | K973908 | Auklet CT Scanner, TSX-003A | Toshiba America Medical Systems, In.C | 1997 | — |
| +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 | — |
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? (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 |
|---|---|---|---|
| * | K941745 | TSX-002A (Xvision) CT ScannerSummary page 1…Scanner, TSX-003A Scanner, Computed Tomography, X-Ray [Fed. Reg. No. 892.1750, Pro. Code: 90JXD] II (per 21 CFR 892.1750) Predicate Device: Toshiba TSX-002A, Xvision [K941745] Reason For Submission New Product Description of this Device: The Auklet is a whole body CT Scanner that employs slip ring te… | 1994 |
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?
- Its one ancestor has no 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?
X-ray imaging of whole body - Computerized Tomography
Including:
Axial
Volumetric (Helical)
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/K973908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973908: Auklet CT Scanner, TSX-003A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973908
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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