LQA · Media, Reusable Image
Radiology · 21 CFR 892.1840 · Class 1
Overview
| Product Code | LQA |
|---|---|
| Device Name | Media, Reusable Image |
| Regulation | 21 CFR 892.1840 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.
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 the limitations in § 892.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K854407 | DIGIRAD REUSABLE IMAGE MEDIA | Digirad Corp. | Mar 10, 1986 | SESE |
Top Applicants
- Digirad Corp. — 1 clearance
