510(k) · Cleared
ClearedPronosco X-Posure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Torsana Osteoporosis Diagnostics A/S · KGI Densitometer, Bone
Cleared on Feb 18, 1999 as substantially equivalent to K913321 (Hologic, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1991. 7 later devices descend from it.
- Decided
- Feb 18, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913321 (1991). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913321 Hologic QDR-2000 X-Ray Bone DensitometerHologic, Inc. · 1991
- This deviceK984178 Pronosco X-Posure SystemTorsana Osteoporosis Diagnostics A/S · 1999
- Descendant · cites it directly · 6 of its ownK082402 Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK121716 TBS InsightMedimaps Group SA · 2012
- Descendant · 3 generations on · 4 of its ownK152299 TBS iNsightMedimaps Group SA · 2016 · Recalled
- Descendant · 4 generations on · 2 of its ownK191112 GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · Recalled
- Descendant · 5 generations on · 0 of its ownK252718 Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082402Osdx Hip BMD SystemImaging Therapeutics, Inc. · 2008 · cites it directly6descendants
- K121716TBS InsightMedimaps Group SA · 2012 · 2 generations on5descendants
- K152299TBS iNsightMedimaps Group SA · 2016 · 3 generations on4descendants
- K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2019 · 4 generations on2descendants
- K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913321 | Hologic QDR-2000 X-Ray Bone Densitometer | Hologic, Inc. | 1991 | — |
| 0 (this device) | K984178 | Pronosco X-Posure System | Torsana Osteoporosis Diagnostics A/S | 1999 | — |
| +1 | K082402 | Osdx Hip BMD System | Imaging Therapeutics, Inc. | 2008 | — |
| +2 | K121716 | TBS Insight | Medimaps Group SA | 2012 | — |
| +3 | K152299 | TBS iNsight | Medimaps Group SA | 2016 | 2 |
| +4 | K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019 | 1 |
| +5 | K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K913321 | Hologic QDR-2000 X-Ray Bone DensitometerSummary page 2…n or Usual Name Pronosco X-posure System™ Classification Name Bone Densitometer Predicate Devices 1. Hologic, Inc.’s QDR 2000 X-Ray Bone Densitometer (K913321) 2. Norland Medical Systems’ Norland 178 Bone Mineral Analyzer (preamendments device) 3. Norland Medical Systems’ pDEXA® Bone De… | 1991 |
| * | K973104 | Norland Model Pdexa Bone DensitometerSummary page 2…nd Medical Systems’ Norland 178 Bone Mineral Analyzer (preamendments device) 3. Norland Medical Systems’ pDEXA® Bone Densitometer with Fracture Risk Assessment Option (K973104) 4. Compumed, Inc.’s Osteogram (preamendments device) Intended Use The Pronosco X-posure System™ is intended for use to estimat… | 1998 |
| * | — | Norland Medical Systems’ Norland 178 Bone Mineral Analyzer Named without a submission number | |
| * | — | Compumed, Inc.’s Osteogram Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082402 | Osdx Hip BMD System | 2008 | 6 |
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 Pronosco X-posure System™ is intended for use to estimate BMD in the forearm and to assess increased risk of osteoporotic fractures according to World Health Organization (“WHO”) criteria. The device is specifically indicated for use to: (1) assist the physician in diagnosing subjects who have already been identified to be at risk of suffering from osteoporosis, together with other known risk factors (i.e., prior history of fractures, advanced age…
Read the full statement (114 words)
The Pronosco X-posure System™ is intended for use to estimate BMD in the forearm and to assess increased risk of osteoporotic fractures according to World Health Organization (“WHO”) criteria. The device is specifically indicated for use to: (1) assist the physician in diagnosing subjects who have already been identified to be at risk of suffering from osteoporosis, together with other known risk factors (i.e., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of calcium and vitamin D, and smoking); and (2) compare the BMD estimate with reference populations of young normals and age matched normals to compute T-scores and Z-scores, respectively.
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/K984178 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984178: Pronosco X-Posure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984178
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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