# FDA 483 - Imagen Technologies Inc. - January 25, 2024

Source: https://www.keypedia.com/records/483/imagen-technologies-inc/95a83db8-1591-4039-b9f0-51b40ec2c671

> FDA 483 for Imagen Technologies Inc. on January 25, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Imagen Technologies Inc.
- Inspection Date: 2024-01-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Imagen Technologies Inc., a manufacturer of Class II AI software including Chest CAD and Fracture Detect, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's complaint handling procedures. Specifically, the company failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, resulting in numerous complaint files lacking essential data for proper investigation and trending of issues.

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/imagen-technologies-inc/8521fdc7-50bf-4268-a2ad-715d4a54dcca

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961