FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OmniTom Elite
K Number: K223447
·
Decision Jun 1, 2023
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
2
Review Days
198
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Basic Information
- Device Name
- OmniTom Elite
- K Number
- K223447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurologica Corporation, A Subsidiary of Samsung
- Date Received
- November 15, 2022
- Decision Date
- June 1, 2023
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K242811 | BodyTom 64 | Mar 14, 2025 | Substantially Equivalent |