510(k) · Cleared
ClearedAccudexa Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schick Technologies, Inc. · KGI Densitometer, Bone
Cleared on Jun 4, 1998 as substantially equivalent to K973104 (Norland Corp., 1998) after a 69-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jun 4, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973104 (1998). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K113616ACCUDXA2Lone Oak Medical Technologies, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973104 | Norland Model Pdexa Bone Densitometer | Norland Corp. | 1998 | — |
| 0 (this device) | K981124 | Accudexa Bone Densitometer | Schick Technologies, Inc. | 1998 | — |
| +1 | K113616 | ACCUDXA2 | Lone Oak Medical Technologies, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 KGI? 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 KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 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 |
|---|---|---|---|
| * | K973104 | Norland Model Pdexa Bone DensitometerSummary page 1…to the Norland pDEXA and Model 178 bone densitometer devices with respcct to the fracture risk claim. The Norland pDEXA device was found to be substantially equivalent (K973104} with regard to claims of fracture risk to the Norland Model 178, which has been determined by CORH to have been in commercial di… | 1998 |
| * | — | Norland Model 178 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113616 | ACCUDXA2 | 2012 | 0 |
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?
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, 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 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.
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/K981124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981124: Accudexa Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981124
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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