What does "capital equipment" refer to in the context of medical devices?

[hirohama naoki]

In design verification for capital equipment, it is sometimes observed that the same device is repeatedly used to increase the sample size. For example, if three units are taken from different lots and each is tested ten times, the total sample size becomes 30. However, the definition of capital equipment remains unclear. While large medical devices such as MRI and CT systems are clearly considered capital equipment, what about reusable devices like ventilators or instruments used in systems like the da Vinci surgical robot? These are likely treated as fixed assets from an accounting perspective, but does the definition of capital equipment in medical devices align with the accounting definition of fixed assets?

 

[Miner]

This may be helpful. I would not try to reconcile an accounting definition with a regulatory definition. Different companies have different accounting definitions of capital equipment, usually based on cost.