ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES
Device Facts
| Record ID | K935157 |
|---|---|
| Device Name | ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES |
| Applicant | Regulatory Consultants TO the Medical Device Indus |
| Product Code | KPX · Radiology |
| Decision Date | Aug 9, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1860 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.
Special Controls
*Classification.* Class II (special 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.
