RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT— 510(k) K894643
Substantially EquivalentLorad Medical Systems, Inc.
FDA 510(k) clearance K894643 for RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT, Substantially Equivalent on 1989-12-14. Applicant: Lorad Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Lorad Medical Systems, Inc.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danbury, CT, US
Recent devices under product code IZL
view allMore clearances from Lorad Medical Systems, Inc.
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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