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aPROMISE X

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220590

by Exini Diagnostics Ab

Identifiers

510(k) Number
K220590 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The aPROMISE X is a dual-energy X-ray absorptiometry (DEXA) system designed for measuring bone mineral density and body composition. It employs low-dose X-ray technology to assess skeletal health, particularly in the detection of osteoporosis and related metabolic conditions, while also providing quantitative analysis of lean mass, fat mass, and visceral fat.

This device is intended for use in clinical settings such as hospitals, research laboratories, and specialized diagnostic centers. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate measurements. The aPROMISE X holds FDA 510(k) clearance under the Traditional pathway and is authorized under the Medical Device Regulation (MDR). It is classified under product code LLZ and falls under the Radiology advisory committee’s review scope.

Frequently asked questions

What clinical applications is the aPROMISE X primarily used for in a hospital setting?

The aPROMISE X is primarily used for measuring bone mineral density to assess skeletal health, particularly for detecting osteoporosis and related metabolic conditions. Additionally, it provides quantitative analysis of body composition, including lean mass, fat mass, and visceral fat, making it valuable for comprehensive patient evaluations in clinical, research, or specialized diagnostic settings.

Is the aPROMISE X a single-use or reusable device, and what maintenance does it require?

The aPROMISE X is a reusable medical device. Since it employs low-dose X-ray technology for precise measurements, it requires regular calibration and maintenance to ensure accuracy and reliability over time. Proper upkeep is essential for sustained performance in clinical environments.

How is the aPROMISE X regulated, and which advisory committee oversees its review?

The aPROMISE X holds FDA 510(k) clearance under the Traditional pathway and is authorized under the Medical Device Regulation (MDR). Its review falls under the Radiology advisory committee (RA), specifically the Radiology (RA) panel, as indicated by its product code (LLZ).

What types of measurements can the aPROMISE X provide beyond bone density?

Beyond bone mineral density, the aPROMISE X offers detailed body composition analysis, including quantification of lean mass, fat mass, and visceral fat. This makes it useful for assessing overall metabolic health and body composition metrics in addition to skeletal evaluations.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Exini Diagnostics Ab

Sources (2)

  • FDA 510(k) K220590 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026