- Patent Title: Method and apparatus for medical devices under regulatory control
-
Application No.: US17576322Application Date: 2022-01-14
-
Publication No.: US11783942B2Publication Date: 2023-10-10
- Inventor: Russell Granneman
- Applicant: KARL STORZ Imaging, Inc.
- Applicant Address: US CA Goleta
- Assignee: KARL STORZ Imaging, Inc.
- Current Assignee: KARL STORZ Imaging, Inc.
- Current Assignee Address: US CA Goleta
- Agent David N. Villalpando
- Main IPC: G16H40/63
- IPC: G16H40/63 ; A61B1/04 ; A61B1/045 ; A61B1/00

Abstract:
Systems, devices, methods, and program products are provided for operating a medical system that is operable within at least two different medical device regulatory classes. A device control module receives an indicator for performing at least one procedure with a medical device. Based on the indicator, it selects a binary image for booting the control module from among multiple images including a controlled-type and a non-controlled type, which operate in different regulatory classes. A controlled-type image, which may be FDA PMA or other regulatory classes, is verified to be unaltered, and is then used to operate as a regulated medical device. The indicator can be automatic or manual. The indicator may result from connection of a specific medical device or peripheral device or may be user input.
Public/Granted literature
- US20220139547A1 Method and Apparatus for Medical Devices Under Regulatory Control Public/Granted day:2022-05-05
Information query