Synchronizer, Ecg / Respirator, Radiographic
A radiographic ECG/respirator synchronizer is a device that coordinates the timing of radiographic exposures with cardiac or respiratory cycles, enabling acquisition of images at specific phases of heart or lung motion to reduce motion blur in cardiac and thoracic radiography. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IXO, regulated under 21 CFR 892.1970, within the Radiology medical specialty.
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Basic Information
- Product Code
- IXO
- Device Class
- FDA class 1
- Regulation Number
- 892.1970
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K854976 | RMI RESPIRATORY GATING SYSTEM MODEL 301 | May 07, 1986 | Substantially Equivalent | Radiation Measurements, Inc. |
| K811587 | SIEMENS ANGIOTRON | Jul 10, 1981 | Substantially Equivalent | Siemens Corp. |
| K810588 | SYNCHRONIZER #208 | Apr 10, 1981 | Substantially Equivalent | Brattle Instrument Corp. |
| K791959 | POST EXTRA SYSTOLIC POSTENTLATOR | Jan 09, 1980 | Substantially Equivalent | Medrad, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.