510(k) Report

510(k) · Cleared

Cleared

Norland Model Pdexa Bone Densitometer

K973104510(k) TraditionalCleared Jan 29, 1998163-day reviewClass II21 CFR 892.1170

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Norland Corp. · KGI Densitometer, Bone

Cleared on Jan 29, 1998 after a 163-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.

Decided
Jan 29, 1998
Review
163 days
Class
Class II
Product code
KGI
Recalls
None
Predicates
0

36 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1998: 6 descendants cleared1999: 2 descendants cleared2000: 2 descendants cleared2012: 3 descendants cleared2008: 5 descendants cleared2002: 1 descendant cleared2003: 1 descendant cleared2004: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2016: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2014: 1 descendant cleared2022: 2 descendants cleared2019: 1 descendant cleared2025: 2 descendants cleared2026: 1 descendant cleared2018: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973104 Norland Model Pdexa Bone DensitometerNorland Corp. · 1998
  2. Descendant · cites it directly · 25 of its ownK983028 Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500…Hologic, Inc. · 1998
  3. Descendant · 2 generations on · 19 of its ownK023398 Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500…Hologic, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 13 of its ownK061561 Hip Structural Analysis Software Option for the Hologic QDR X-Ray…Hologic, Inc. · 2006
  5. Descendant · 4 generations on · 7 of its ownK072664 GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008
  6. Descendant · 2 generations on · 7 of its ownK082317 GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co. · 2008

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

1998: 61999: 22000: 22002: 12003: 12004: 22006: 12008: 52009: 12012: 32014: 12016: 22018: 12019: 12021: 12022: 22023: 12025: 22026: 1
1998high 6 (1998) · low 0 (2001)2026

Most influential descendants

Showing 5 of 36 · See all
  • K983028Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…Hologic, Inc. · 1998 · cites it directly25descendants
  • K023398Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoveryHologic, Inc. · 2002 · 2 generations on19descendants
  • K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone DensitometersHologic, Inc. · 2006 · 3 generations on13descendants
  • K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia · 2008 · 4 generations on7descendants
  • K082317GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co. · 2008 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973104Norland Model Pdexa Bone DensitometerNorland Corp.1998—
+1K983028Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000…Hologic, Inc.1998—
+2K023398Hologic QDR X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, DiscoveryHologic, Inc.20021
+3K061561Hip Structural Analysis Software Option for the Hologic QDR X-Ray Bone…Hologic, Inc.2006—
+4K072664GE Lunar Femur Strength SoftwareGe Medical Systems Ultrasound and Primary Care Dia2008—
+2K082317GE Lunar Frax 10-Year Fracture Risk Software OptionGeneral Electric Co.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199860
199920
200020
200210
200310
200420
200610
200850
200910
201230
201410
201620
201810
201910
202110
202220
202310
202520
202610
FIG. 1 — Lineage of K973104, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Norland-Cameron Model 178 Bone Mineral Analyzer (Model 178)
Named without a submission number
—

What descends from it? (36)

See all 36

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983028Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500…Hologic, Inc.199825
K984178Pronosco X-Posure SystemTorsana Osteoporosis Diagnostics A/S19997
K980569Fracture Risk Assessment Capability for Norland X-Ray Bone DensitometersNorland Corp.19984
K981124Accudexa Bone DensitometerSchick Technologies, Inc.19981
K980125Reference Population for Norland Apollo X-Ray Bone DensitometerNorland Corp.19981
K980289Fracture Risk Assessment for the Norland Sxa 3000 Bone DensitometerNorland Corp.19980

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?

  • Of its descendants, K983028 (Hologic, Inc., 1998) has gone furthest, with 25 descendants of its own.

How does its category compare?

All KGI devices

KGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGI

3in 2025

2007: 22008: 52009: 12011: 22012: 52013: 12014: 22016: 22018: 12019: 12022: 22023: 12025: 32026 (partial year): 2
2007high 5 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGI

156in 2025

2008: 173 days median2012: 142 days median2025: 156 days median
2007high 173 (2008) · low 142 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGI

1in 2016

2008: 62009: 92011: 12016: 1
2007high 9 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGI

8in 2025

2008: 22009: 32011: 52012: 12013: 12014: 22016: 12017: 162018: 62020: 22021: 12022: 12023: 22024: 22025: 8
2007high 16 (2017) · low 0 (2007)2025

MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
2008517362
20091—93
20100—00
20112—15
2012514201
20131—01
20142—02
20150—00
20162—11
20170—016
20181—06
20191—00
20200—02
20210—01
20222—01
20231—02
20240—02
2025315608
20262—0—

What is it indicated for?

The bone density estimates from the Norland pDEXA™ Bone Densitometer 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.

More from Norland Corp.

15 FDA decisions under this applicant name. See the company

  • K980289Fracture Risk Assessment for the Norland Sxa 3000 Bone DensitometerNorland Corp. · 1998
  • K980569Fracture Risk Assessment Capability for Norland X-Ray Bone DensitometersNorland Corp. · 1998
  • K980125Reference Population for Norland Apollo X-Ray Bone DensitometerNorland Corp. · 1998
  • K973459Norland Body Composition Option for Norland Dexa Bone DensitometersNorland Corp. · 1998
  • K972882ApolloNorland Corp. · 1997

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The KGI category page

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https://510kreport.com/device/K973104 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973104: Norland Model Pdexa Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973104

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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