FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
InkSpace Imaging Pediatric Body Array
K Number: K213397
·
Decision Dec 17, 2021
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
478
Applicant Total
4
Review Days
60
Basic Information
- Device Name
- InkSpace Imaging Pediatric Body Array
- K Number
- K213397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- InkSpace Imaging, Inc.
- Date Received
- October 18, 2021
- Decision Date
- December 17, 2021
- Product Code
- MOS
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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