InkSpace Imaging Pediatric Body Array
FDA 510(k) clearance K213397 · decided 2021-12-17
Clearance details
- K-number
- K213397
- Device name
- InkSpace Imaging Pediatric Body Array
- Applicant
- Inkspace Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-18
- Decision date
- 2021-12-17
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.