Modified QDR-1000 X-Ray Bone Densitometer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K890999 FDA 510(k)
- FDA Product Code
- KGI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1170 FDA 510(k)
- Regulation Number
- 892.1170 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
The Modified QDR-1000 X-Ray Bone Densitometer is a Class II medical device manufactured by Hologic, Inc. It received FDA 510(k) clearance (K890999) on December 21, 1989, and is classified under product code KGI with regulation number 892.1170.
Frequently asked questions
What is the Modified QDR-1000 X-Ray Bone Densitometer used for?
It is intended to measure bone density and mineral content by X-ray transmission through bone and adjacent tissues, supporting clinical assessment of bone health.
Who manufactures the Modified QDR-1000 X-Ray Bone Densitometer and where are they located?
It is manufactured by Hologic, Inc., located at 590 Lincoln St., Waltham, MA 02154, United States.
What regulatory clearance does the Modified QDR-1000 X-Ray Bone Densitometer have?
It received FDA 510(k) clearance under number K890999 on December 21, 1989, and is classified as a Class II device under product code KGI and regulation 892.1170.
What type of technology does the Modified QDR-1000 X-Ray Bone Densitometer use to measure bone density?
It uses X-ray transmission measurements through bone and adjacent tissues to assess bone density and mineral content, with signal analysis and display components.
Is the Modified QDR-1000 X-Ray Bone Densitometer a new device or based on a prior model?
It is a modified version of the QDR-1000 X-Ray Bone Densitometer, with changes evaluated for substantial equivalence under the FDA 510(k) process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODIFIED QDR-1000 X-RAY BONE DENSITOMETER - fda.innolitics.com, Hologic Modified QDR-1000 X-Ray Bone Densitometer, MODIFIED QDR-1000 X-RAY BONE DENSITOMETER 510(k)… - FDA.report, K883280 - Hologic Qdr-1000 X-ray Bone Densitomete...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890999 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA 510(k) K890999 24 fields · synced Sep 22, 2026