FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BodyTom 64
K Number: K213649
·
Decision Apr 29, 2022
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
8
Review Days
161
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Basic Information
- Device Name
- BodyTom 64
- K Number
- K213649
- 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
- Date Received
- November 19, 2021
- Decision Date
- April 29, 2022
- 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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Other Clearances by Neurologica Corporation
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|---|---|---|---|
| K250928 | OmniTom Elite with PCD | Sep 8, 2025 | Substantially Equivalent |
| K233767 | OmniTom Elite | Jun 10, 2024 | Substantially Equivalent |
| K171183 | OmniTom | Aug 18, 2017 | Substantially Equivalent |
| K142697 | NExCT 7 | Dec 23, 2014 | Substantially Equivalent |
| K102677 | BODYTOM NL 4000 | Mar 24, 2011 | Substantially Equivalent |
| K090811 | INSPIRA HD, MODEL: NL1000 | Aug 27, 2009 | Substantially Equivalent |
| K051765 | CERETOM, MODEL NL3000 | Jul 14, 2005 | Substantially Equivalent |