21 CFR 892.2010 — Device, Digital Image Storage, Radiological
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.2010
Identification
A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | 1 | 55 | |
| NFF | Device, Storage, Images, Ophthalmic | 1 | 1 |
