K103265 · Hologic, Inc. · KGI · Mar 16, 2011 · Radiology
Device Facts
Record ID
K103265
Device Name
NHANES WHOLE BODY DXA REFERENCE DATABASE
Applicant
Hologic, Inc.
Product Code
KGI · Radiology
Decision Date
Mar 16, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1170
Device Class
Class 2
Indications for Use
The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body % fat, android % fat, gynoid % fat, android/gynoid ratio, and body mass index. The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional. These body composition values are useful to health care professionals in their management of diseases and conditions where the disease or conditions itself, or its treatment, can affect the relative amounts of fat and lean tissue. The Hologic Whole Body DXA Reference Database software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and vistic fibrosis. DXA body composition is a useful alternative to hydrostatic weighting and skin fold measurements.
Device Story
Software add-on for Hologic QDR bone densitometers; processes DXA scan data to calculate regional/whole body bone mineral density, lean/fat tissue mass, and derivative body composition metrics (e.g., % fat, BMI, android/gynoid ratio). Displays results via user-defined statistical formats, trends, and color image mapping. Compares patient data against reference populations. Used by clinicians in clinical settings to monitor conditions like obesity, AIDS/HIV, and chronic renal failure. Does not diagnose, recommend treatment, or quantify effectiveness; serves as decision-support tool for professional judgment.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and comparison to predicate device.
Technological Characteristics
Software-based reference database for DXA bone densitometers. Operates on Hologic QDR hardware. Provides body composition analysis and reference population comparison. No changes to fundamental scientific technology or measurement algorithms from previous software versions.
Indications for Use
Indicated for use by healthcare professionals to manage diseases/conditions affecting fat and lean tissue composition, including chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. Used as an alternative to hydrostatic weighing and skin fold measurements.
Regulatory Classification
Identification
A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
Body Composition Software Option for GE Lunar DEXA Bone Densitometers (K071570)
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Hologic, Inc .: November 3, 2010
# F. 510(k) Summary
MAR 1 6 2011
# Manufacturing Establishment and Contact Information F.1
### Manufacturer Name and Address: F.1.1
Hologic. Inc. 35 Crosby Drive Bedford, MA 01730
#### F.1.2 Establishment Registration Number:
1221300
#### F.1.3 Name, Title, and Telephone Number of Contact:
Christina Hurton Regulatory Affairs Specialist Phone: (781) 999-7781 Fax: (866) 652-8674 Christina.Hurton@hologic.com
# F.2 Device Identification
#### F.2.1 Device Trade Name:
Hologic Whole Body DXA Reference Database
#### F.2.2 Common / Usual Name:
Database for Bone Densitometers
#### Proposed Intended Use: F.2.3
The Hologic Whole Body DXA Reference Database software used on Hologic QDR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body % fat, android % fat, gynoid % fat, android/gynoid ratio, and body mass index. The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.
These body composition values are useful to health care professionals in their management of diseases and conditions where the disease or conditions itself, or its treatment, can affect the relative amounts of fat and lean tissue. The Hologic Whole Body DXA Reference Database software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make
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K103265
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Hologic, Inc.: November 3, 2010
these judgments. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and vistic fibrosis. DXA body composition is a useful alternative to hydrostatic weighting and skin fold measurements.
### F.3 Device Classification
- F.3.1 Classification:
Class II
#### F.3.2 Classification Name and Rule
Bone Densitometer: 21 CFR 892.1170
- F.3.3 Classification Panel
Radiology
- F.3.4 Product Code
90 KGI
#### F.3.5 Predicate Devices
- o 510(k) No .: K071570 Trade Name: Body Composition Software Option for GE Lunar DEXA Bone Densitometers June 27, 2007 SE Date: Manufacturer: GE Medical Systems, Lunar
# F.4 Conclusion:
The Hologic Whole Body DXA Reference Database does not change any of the algorithms or measured values of fat mass, lean mass or bone mass from the previously cleared APEX 2.0 Software (K072847). It does not change the fundamental scientific technology and no new safety or efficacy concerns are raised.
The Hologic Whole Body DXA Reference Database is substantially equivalent to the presently marketed predicate device: Body Composition Software Option for GE Lunar DEXA Bone Densitometers (K071570).
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christina Hurton Regulatory Affairs Specialist Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730
MAR 1 6 2011
Re: K103265
Trade/Device Name: Hologic Whole Body DXA Reference Database Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: November 3, 2010 Received: November 26, 2010
Dear Ms. Hurton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Hologic, Inc .: November 3, 2010
Hologic Whole Body DXA Reference Database 510(k) Premarket Notification
# A.2 Indication for Use Statement
510(k) Number (if known): K 103 2105
Device Name:
Hologic Whole Body DXA Reference Database
Indication for Use:
The Hologic Whole Body DXA Reference Database software used on Hologic ODR bone densitometers measures the regional and whole body bone mineral density, lean and fat tissue mass and calculates derivative values of bone mineral content, area, soft tissue mass, regional soft tissue mass, total soft tissue mass, fat free mass, regional and total soft tissue mass ratios, % fat, regional % fat, total body % fat, android % fat, gynoid % fat, android/gynoid ratio, and body mass index. The values can be displayed in user-defined statistical formats and trends with color image mapping, and compared to reference populations at the sole discretion of the health care professional.
These body composition values are useful to health care professionals in their management of diseases and conditions where the disease or conditions itself, or its treatment, can affect the relative amounts of fat and lean tissue. The Hologic Whole Body DXA Reference Database software does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. Only the health care professional can make these judgments. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HIV, and cystic fibrosis. DXA body composition is a useful alternative to hydrostatic weighting and skin fold measurements.
Prescription Use X (Part 21 CFR 801 Subpart D): AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S Pasto
(Division Sign-Off)
510K. K103265
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
