IXO · Synchronizer, Ecg / Respirator, Radiographic
Radiology · 21 CFR 892.1970 · Class 1
Overview
| Product Code | IXO |
|---|---|
| Device Name | Synchronizer, Ecg / Respirator, Radiographic |
| Regulation | 21 CFR 892.1970 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K854976 | RMI RESPIRATORY GATING SYSTEM MODEL 301 | Radiation Measurements, Inc. | May 7, 1986 | SESE |
| K811587 | SIEMENS ANGIOTRON | Siemens Corp. | Jul 10, 1981 | SESE |
| K810588 | SYNCHRONIZER #208 | Brattle Instrument Corp. | Apr 10, 1981 | SESE |
| K791959 | POST EXTRA SYSTOLIC POSTENTLATOR | Medrad, Inc. | Jan 9, 1980 | SESE |
Top Applicants
- Siemens Corp. — 1 clearance
- Radiation Measurements, Inc. — 1 clearance
- Medrad, Inc. — 1 clearance
- Brattle Instrument Corp. — 1 clearance
