FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
SKAN C PULSAR
K Number: K251893
·
Decision Dec 16, 2025
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
4
Review Days
179
Basic Information
- Device Name
- SKAN C PULSAR
- K Number
- K251893
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skanray Technologies Limited
- Date Received
- June 20, 2025
- Decision Date
- December 16, 2025
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWB), ordered by most recent decision date.
C-beam
FDA 510(k)
FDA Class 2
·Radiology
Intelligent NR
FDA 510(k)
FDA Class 2
·Radiology
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
FDA 510(k)
FDA Class 2
·Radiology
ARTIS genio floor; ARTIS icono.explore floor
FDA 510(k)
FDA Class 2
·Radiology
BELLIGER ACE
FDA 510(k)
FDA Class 2
·Radiology
Trinias
FDA 510(k)
FDA Class 2
·Radiology