UNiD Spine Analyzer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K180091 ↗

FDA product code

LLZ

Device class

Class II

Regulation

21 CFR Part 892.2050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

• IB3D™ PL Spinal System B241C07062209 Open recall

  Class II

  FDA 510(k) K241164 Active Cleared 6 Sep 2024 GUDID on market

• Pass LP Spinal System B02211070

  Class II

  FDA 510(k) K141398 Active Cleared 9 Jan 2015 GUDID on market

• Pass LP B02241104

  Class II

  GUDID on market

• UNiD ROD B33125512-01

  Class II

  GUDID on market

• Pass LP Spinal System B02175510

  Class II

  FDA 510(k) K141398 Active Cleared 9 Jan 2015 GUDID on market

• Pass LP B02215535

  Class II

  GUDID on market

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• What types of spinal measurements and analyses can the UNiD Spine Analyzer perform, and how does it assist in surgical planning?

  The UNiD Spine Analyzer is designed to help healthcare professionals view, measure, and analyze radiological images of the spine. It supports both generic and spine-specific measurements, which are critical for assessing spinal alignment, curvature, and anatomical details. By providing precise data on these parameters, it aids in detailed surgical planning for orthopedic procedures, ensuring clinicians have accurate information to guide interventions.

• Is the UNiD Spine Analyzer a standalone software tool, or does it require integration with other imaging systems?

  The UNiD Spine Analyzer is supplied as a standalone software solution intended for use in clinical settings where radiological imaging is performed. While it is designed to work with radiological images, the exact integration requirements (e.g., compatibility with PACS systems or specific imaging modalities) are not detailed in the provided data. Clinicians should verify compatibility with their existing imaging infrastructure before implementation.

• How is the UNiD Spine Analyzer classified under FDA regulations, and what does this mean for its use in clinical settings?

  The UNiD Spine Analyzer is classified under FDA product code LLZ and was cleared via a 510(k) submission (K180091) with a substantially equivalent (SESE) determination by the Radiology (RA) Advisory Committee. This classification means it is deemed comparable to legally marketed devices of a similar type, allowing its use in clinical settings for viewing, measuring, and analyzing spine radiographs as described. The clearance does not imply sterility or single-use requirements, as it is a reusable software tool.

• Does the UNiD Spine Analyzer require any special storage conditions, and is it reusable or single-use?

  Since the UNiD Spine Analyzer is a reusable software tool, it does not have physical storage requirements like sterile packaging or expiration dates. However, as with all software, it should be stored on secure, compatible hardware to prevent data corruption or unauthorized access. The manufacturer’s guidelines (not provided here) should be followed for optimal performance and maintenance, including software updates and system compatibility.

• What kind of radiological images can the UNiD Spine Analyzer analyze, and does it support measurements for specific spinal conditions?

  The UNiD Spine Analyzer is designed to analyze radiological images of the spine, including X-rays and other imaging modalities commonly used for spinal assessment. While it performs generic and spine-specific measurements, the exact conditions or pathologies it targets (e.g., scoliosis, degenerative disc disease) are not specified in the data. Its primary function is to assist clinicians in surgical planning by providing precise anatomical and alignment data from these images.