510(k) K813032
- Device
- ZIKON 100 DIGITAL X-RAY SYSTEM
- Applicant
- KONTRON INSTRUMENTS, INC.
- 510(k) number
- K813032
- Product code
- JAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-24
- Date received
- 1981-10-28
- Regulation
- 892.1660
- Classification name
- System, X-ray, Fluoroscopic, Non-image-intensified
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011050570
- 3021008900
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JAB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970782 | IMAGING JET SYSTEM | General Robotic Devices, Inc. | 1997-11-13 |
Legacy Summary#
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FDA Review#
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