510(k) · Cleared
ClearedHologic Visceral Fat Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · KGI Densitometer, Bone
Cleared on Mar 6, 2012 as substantially equivalent to K103730 (Ge Medical Systems Ultrasound and Primary Care Dia, 2011) and 1 other predicate after a 113-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 6, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K935454 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK935454 DPX Tissue Quantification OutputLunar Corp. · 1995
- 3 generations backK973459 Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
- 2 generations backK071570 GE Lunar Body Composition SoftwareGe Medical Systems Lunar · 2007
- 1 generation backK103265 Nhanes Whole Body Dxa Reference DatabaseHologic, Inc. · 2011
- This deviceK113356 Hologic Visceral Fat SoftwareHologic, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935454 | DPX Tissue Quantification Output | Lunar Corp. | 1995 | — |
| −3 | K973459 | Norland Body Composition Option for Norland Dexa Bone Densitometers | Norland Corp. | 1998 | — |
| −2 | K071570 | GE Lunar Body Composition Software | Ge Medical Systems Lunar | 2007 | — |
| −1 | K103265 | Nhanes Whole Body Dxa Reference Database | Hologic, Inc. | 2011 | — |
| 0 (this device) | K113356 | Hologic Visceral Fat Software | Hologic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K103730 | GE Lunar Visceral Fat SoftwareSummary page 3…03265). The features and functions are substantially equivalent to those of the indicated commercially distributed device (GE Lunar Visceral Fat Software K103730) with regard to intended use, performance, safety and effectiveness Section 5 Halo gic Proprietary and… | 2011 |
| * | K103265 | Nhanes Whole Body Dxa Reference DatabaseSummary page 2…Trade Name: GE Lunar Visceral Fat Software SE Date: 5/6/2011 Manufacturer: GE Medical Systems Lunar *510(k) No.: K(103265 Trade Name: Hologic NHANES Whole Body DXA Reference Database SE Date: 3/16/2011 Manufactur… | 2011 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends. The estimated visceral fat…
Read the full statement (152 words)
The Hologic Visceral Fat Software used on Hologic Discovery bone densitometer total body scans estimates the visceral adipose tissue (visceral fat) content within the android region in an adult male or female population, excluding pregnant women. The content that is estimated is the Visceral Fat Area, Visceral Fat Mass, and Visceral Fat Volume. These values can be displayed in user-defined statistical formats and trends.
The estimated visceral fat content is useful to health care professionals in their management of diseases/conditions where the disease/condition itself, or its treatment can affect the relative amounts of visceral fat content in the android region. The Hologic Visceral Fat software does not diagnose disease, or recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases, conditions for which visceral fat estimation is useful include hypertension, impaired fasting glucose, impaired glucose tolerance, diabetes mellitus, dyslipidemia, and metabolic syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113356: Hologic Visceral Fat Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113356
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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