Storz Alpha II Biometric Ruler
by Storz Instrument Co. 510(k)
Active
510(k) K860553
Overview
The Storz Alpha II Biometric Ruler is a Biometric Ruler (Device Type: ITX) designed for precise measurement in radiologic imaging procedures. It provides accurate dimensional assessment of anatomical structures, supporting diagnostic and procedural planning in radiology. The device is classified under the FDA’s Radiology advisory committee and is intended for use in imaging workflows requiring linear measurements.
This reusable device is supplied sterile or non-sterile as required for clinical use, with no specific MRI safety restrictions noted. It is available in standard configurations aligned with radiologic measurement standards and must be maintained per manufacturer guidelines. The device holds FDA 510(k) clearance under K-number K860553, issued in 1986, and is regulated as a Class II medical device under the Traditional 510(k) pathway. Storage and handling follow standard radiologic instrument protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860553 | Date16 Jun 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ITX
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Storz Instrument Co.
Questions
What is the Storz Alpha II Biometric Ruler used for?
The Storz Alpha II Biometric Ruler is designed specifically for precise linear measurements in radiologic imaging procedures. It helps clinicians assess anatomical structures accurately, which is essential for diagnostic evaluations and procedural planning in radiology. By providing reliable dimensional data, it supports better decision-making during imaging workflows.
Is the Storz Alpha II Biometric Ruler reusable or single-use?
The Storz Alpha II Biometric Ruler is a reusable device. It can be supplied either sterile or non-sterile depending on the clinical requirements, allowing for flexibility in different procedural settings. Proper maintenance and cleaning per manufacturer guidelines are necessary to ensure its continued accuracy and sterility.
What regulatory pathway does the Storz Alpha II Biometric Ruler follow?
The Storz Alpha II Biometric Ruler holds FDA 510(k) clearance under the Traditional 510(k) pathway, with a clearance number of K860553. It was classified under the Radiology advisory committee and is categorized as a Class II medical device. This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device already on the market.
Are there any special storage or handling instructions for this device?
The Storz Alpha II Biometric Ruler should be stored and handled according to standard radiologic instrument protocols. Since it is reusable, it must be cleaned and maintained properly to preserve its precision and sterility. Follow the manufacturer’s guidelines to ensure optimal performance and longevity of the device.
Does the Storz Alpha II Biometric Ruler have any MRI safety restrictions?
No specific MRI safety restrictions are noted for the Storz Alpha II Biometric Ruler. However, it is always recommended to verify compatibility with the specific MRI system and protocols in use, as safety can depend on various factors including the environment and other equipment involved.