DXL Calscan Bone Densitometer
by Demetech AB
510(k) K033550
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033550 | Date5 May 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Dxl Calscan
- 510(k) Number
- FDA product code
- KGI
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1170
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DXL Calscan is a bone densitometer designed for measuring bone mineral density (BMD) using dual X-ray absorptiometry (DXA) technology. It combines pixel-level laser thickness measurements with radiographic imaging to enhance precision in assessing skeletal integrity, particularly for fracture risk evaluation. This device is classified as a Class II medical device under regulatory standards, ensuring compliance with stringent performance and safety criteria. Its primary application lies in radiology, where accurate BMD quantification supports clinical decision-making for osteoporosis and related conditions.
The DXL Calscan is supplied as a reusable medical device intended for use in radiology departments, outpatient clinics, or private physician offices. It operates under FDA 510(k) clearance (K033550) and adheres to regulatory requirements outlined in 21 CFR 892.1170, ensuring its suitability for clinical bone health assessments. The device is not classified as single-use and requires proper calibration, maintenance, and storage in accordance with manufacturer guidelines to preserve accuracy. Its design incorporates MRI-safe materials, though specific safety parameters should be verified per facility protocols.
Other devices from DemeTECH Corp
Questions
AI-generated answers, 1 Oct 2026
What is the DXL Calscan used for in clinical settings?
The DXL Calscan is a bone densitometer designed specifically for measuring bone mineral density (BMD) using dual X-ray absorptiometry (DXA) technology. It enhances precision by integrating pixel-level laser thickness measurements with radiographic imaging, making it particularly useful for evaluating skeletal integrity and assessing fracture risk in patients with osteoporosis or related conditions. Clinicians rely on its accurate BMD quantification to support clinical decision-making in radiology, outpatient clinics, or private offices.
How is the DXL Calscan supplied and intended for use?
The DXL Calscan is supplied as a reusable medical device, meaning it is not intended for single-use applications. It is engineered for use in radiology departments, outpatient clinics, or private physician offices where bone health assessments are conducted. Proper calibration, maintenance, and storage are required to ensure its accuracy and reliability over repeated use, as outlined in the manufacturer’s guidelines.
Is the DXL Calscan sterile, and how should it be handled?
The DXL Calscan is not classified as a sterile device. Since it is reusable, it must be cleaned, disinfected, and maintained according to established protocols to prevent contamination and ensure patient safety. The manufacturer provides specific instructions for handling, storage, and periodic maintenance to preserve the device’s performance and compliance with regulatory standards.
Does the DXL Calscan have any special considerations for MRI compatibility?
The DXL Calscan incorporates MRI-safe materials, which means it is designed to be used in environments where MRI procedures are performed without posing a risk to patients undergoing MRI scans. However, facilities should verify the specific safety parameters and guidelines provided by Demetech AB to ensure compatibility with their MRI protocols and equipment.
What regulatory approvals does the DXL Calscan hold, and how does it classify?
The DXL Calscan holds FDA 510(k) clearance under the reference number K033550, confirming its substantial equivalence to a predicate device. It is classified as a Class II medical device under regulatory standards, adhering to the requirements outlined in 21 CFR 892.1170. This classification ensures it meets stringent performance and safety criteria for use in clinical bone health assessments.