510(k) · Cleared
ClearedAnatom 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analogic Corp. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 6, 1997 as substantially equivalent to K944131 (Analogic Corp., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 37 later devices descend from it.
- Decided
- Mar 6, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944131 (1995). 37 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK944131 Anatom 2000Analogic Corp. · 1995
- This deviceK964890 Anatom 2000Analogic Corp. · 1997
- Descendant · cites it directly · 27 of its ownK051765 Ceretom, Model NL3000Neurologica Corporation · 2005
- Descendant · cites it directly · 18 of its ownK982631 Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998
- Descendant · 2 generations on · 17 of its ownK991278 Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999
- Descendant · 3 generations on · 16 of its ownK014240 ProntoHitachi Medical Systems America, Inc. · 2002
- Descendant · 4 generations on · 15 of its ownK040902 Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K051765Ceretom, Model NL3000Neurologica Corporation · 2005 · cites it directly27descendants
- K982631Philips Tomoscan CSPhilips Medical Systems, Inc. · 1998 · cites it directly18descendants
- K991278Philips Tomoscan AV-NTPhilips Medical Systems North America, Inc. · 1999 · 2 generations on17descendants
- K014240ProntoHitachi Medical Systems America, Inc. · 2002 · 3 generations on16descendants
- K040902Hitachi PrestoHitachi Medical Systems America, Inc. · 2004 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944131 | Anatom 2000 | Analogic Corp. | 1995 | — |
| 0 (this device) | K964890 | Anatom 2000 | Analogic Corp. | 1997 | — |
| +1 | K051765 | Ceretom, Model NL3000 | Neurologica Corporation | 2005 | — |
| +1 | K982631 | Philips Tomoscan CS | Philips Medical Systems, Inc. | 1998 | — |
| +2 | K991278 | Philips Tomoscan AV-NT | Philips Medical Systems North America, Inc. | 1999 | — |
| +3 | K014240 | Pronto | Hitachi Medical Systems America, Inc. | 2002 | — |
| +4 | K040902 | Hitachi Presto | Hitachi Medical Systems America, Inc. | 2004 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K944131 | Anatom 2000Summary page 1510(k) Premarket Notification Number K944131 SUMMARY (1) Submitted by: Analogic Corporation Centennial Industrial Park 8 Centennial Drive _ Peabody, Ma. 01960 MAR -6 1997… | 1995 |
What descends from it? (37)
See all 372 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)
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, K051765 (Neurologica Corporation, 2005) has gone furthest, with 27 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 Anatom 2000 is a whole body CT scanning system. It is intended to be used as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
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/K964890 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964890: Anatom 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964890
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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