FDA Clears DeepXray Spina AI Software for Spinal Radiograph Analysis

FDA 510(k) clearance granted to Alpha Intelligence Manifolds for DeepXray Spina, an AI-based software for spinal radiograph interpretation (product code SAO). Clinical performance data not reported in clearance notice.

• Device: DeepXray Spina by Alpha Intelligence Manifolds, Inc.; cleared under FDA 510(k) pathway (product code SAO, radiology devices).
• Product code SAO covers computer-aided detection/diagnosis software for radiographic imaging; exact predicate device not specified in the clearance snippet.
• No sensitivity, specificity, or AUC figures are available in the source notice; clinical validation details would appear in the full 510(k) summary on FDA's CDRH database.

Automated summary

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