FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
SM-IV
K Number: K232185
·
Decision Aug 21, 2023
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
26
Review Days
28
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
- SM-IV
- K Number
- K232185
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sedecal., Sa.
- Date Received
- July 24, 2023
- Decision Date
- August 21, 2023
- 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
Other Clearances by Sedecal., Sa.
| K Number | Device Name | ||
|---|---|---|---|
| K222951 | SM-V | Nov 21, 2022 | Substantially Equivalent |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | Jul 18, 2022 | Substantially Equivalent |
| K212291 | PHOENIX | Sep 14, 2021 | Substantially Equivalent |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | Feb 1, 2021 | Substantially Equivalent |
| K202293 | Radiographic System Challenge X | Oct 7, 2020 | Substantially Equivalent |
| K192936 | Soltus 500 | Nov 15, 2019 | Substantially Equivalent |
| K192011 | PhoeniX | Sep 25, 2019 | Substantially Equivalent |
| K191813 | MobileDiagnost wDR 2.2 | Aug 2, 2019 | Substantially Equivalent |
| K173299 | DRAGON X SPSL4HC, DRAGON X SPSL8HC | Jan 26, 2018 | Substantially Equivalent |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | Jul 6, 2016 | Substantially Equivalent |