X-Caliber Model 1000 Bone Mineral Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K871553 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)
The X-Caliber Model 1000 Bone Mineral Analyzer is a Densitometer, Bone, designed to measure bone density and mineral content using x-ray or gamma ray transmission. It quantifies skeletal mineralisation through precise radiologic assessment, enabling diagnostic evaluation of osteoporosis and related metabolic bone disorders.
This device is supplied as a Class II medical instrument, intended for use in radiology settings. It operates as a reusable system with no specified sterility requirements, though adherence to standard infection control protocols is recommended. The analyzer is MRI-unsafe and requires proper calibration and maintenance per manufacturer guidelines. Authorised under FDA 510(k) clearance (K871553) and regulated under 21 CFR 892.1170.
Frequently asked questions
What clinical conditions is the X-Caliber Model 1000 Bone Mineral Analyzer primarily used to evaluate?
The X-Caliber Model 1000 Bone Mineral Analyzer is designed to measure bone density and mineral content, enabling diagnostic evaluation of osteoporosis and related metabolic bone disorders. It quantifies skeletal mineralization through precise radiologic assessment using x-ray or gamma ray transmission.
Is the X-Caliber Model 1000 Bone Mineral Analyzer single-use or reusable, and what infection control measures should be followed?
The X-Caliber Model 1000 is a reusable system, meaning it is intended for repeated use in radiology settings. While it does not have specified sterility requirements, standard infection control protocols must be strictly followed to ensure patient safety and device integrity.
Can this device be used in an MRI environment, and what maintenance is required?
No, the X-Caliber Model 1000 Bone Mineral Analyzer is MRI-unsafe, so it cannot be used in an MRI environment. The device requires proper calibration and maintenance as outlined in the manufacturer’s guidelines to ensure accurate and reliable performance.
What regulatory pathway was followed for FDA clearance of this device, and where is it classified?
The X-Caliber Model 1000 received FDA clearance through a Traditional 510(k) pathway (K871553) and is classified as a Class II medical device under 21 CFR 892.1170. It was determined to be substantially equivalent to a predicate device and is regulated under the Radiology advisory committee category.
How many unique registration numbers are associated with this device, and what does this indicate?
The device has 23 unique registration numbers listed in the FDA database, which reflects multiple units or configurations distributed under the same model. These numbers correspond to its classification as a Densitometer, Bone and its use in Radiology settings, ensuring traceability for compliance and inventory purposes.
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: X-caliber Model 1000 Bone Mineral Analyzer, Hologic X-Caliber 1000 Bone Mineral Analyzer - allmed.wiki, X-CALIBER MODEL 1000 BONE MINERAL ANALYZER - fda.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K871553 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA 510(k) K871553 24 fields · synced Sep 19, 2026