RADIOLOGICAL MARKING PEN
Device Facts
| Record ID | K852160 |
|---|---|
| Device Name | RADIOLOGICAL MARKING PEN |
| Applicant | Truett Laboratories, Inc. |
| Product Code | JAC · Radiology |
| Decision Date | Jul 18, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1640 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.