FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOBILE X-RAY FLOOR STAND
K Number: K912400
·
Decision Aug 9, 1991
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
3
Review Days
71
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MOBILE X-RAY FLOOR STAND
- K Number
- K912400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dntl Corp.
- Date Received
- May 30, 1991
- Decision Date
- August 9, 1991
- Product Code
- IZL
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZL), ordered by most recent decision date.
Portable DR Imaging System
FDA 510(k)
FDA Class 2
·Radiology
RAYMO Mobile X-ray System (Model: RAYMO)
FDA 510(k)
FDA Class 2
·Radiology
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
FDA 510(k)
FDA Class 2
·Radiology
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
FDA 510(k)
FDA Class 2
·Radiology
Airbile-100
FDA 510(k)
FDA Class 2
·Radiology
Mobile X-ray unit (!M1)
FDA 510(k)
FDA Class 2
·Radiology