The following data is part of a premarket notification filed by Inkspace Imaging, Inc. with the FDA for Inkspace Imaging Pediatric Body Array.
| Device ID | K213397 |
| 510k Number | K213397 |
| Device Name: | InkSpace Imaging Pediatric Body Array |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | InkSpace Imaging, Inc. 5635 West Las Positas Blvd Suite 403/404 Pleasanton, CA 94588 |
| Contact | Peter Fischer |
| Correspondent | Taras Bouzakine Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-18 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008041326 | K213397 | 000 |