| Primary Device ID | 00860008041364 |
| NIH Device Record Key | dff6e547-44fc-4925-b8ca-00556a6a5505 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Snuggle Pediatric Array, 1.5T |
| Version Model Number | SBA24SH15B |
| Company DUNS | 080330758 |
| Company Name | Inkspace Imaging, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00860008041364 - Snuggle Pediatric Array, 1.5T | 2026-01-30The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Siemens 1.5 Tesla (1.5T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized. The space dinosaur theme is child friendly and designed to help reduce anxiety during the MR scan. |
| 00860008041364 - Snuggle Pediatric Array, 1.5T | 2026-01-30 The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Siemens 1.5 Tesla (1.5T) M |
| 00860008041388 - Silhouette Body Array, 1.5T | 2026-01-30 The InkSpace Imaging Silhouette Body Array is a phased array, receive-only coil designed to work on Siemens 1.5 Tesla (1.5T) MRI |
| 00860008041333 - Snuggle Pediatric Array | 2024-12-03 The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on GE 3.0 Tesla (3.0T) MRI sc |
| 00860008041357 - Nuzzle Veterinary Array | 2024-12-03 The InkSpace Imaging Nuzzle Veterinary Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) M |
| 00860008041302 - Snuggle Pediatric Array | 2024-02-16 The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) M |
| 00860008041319 - Silhouette Adult Array | 2024-02-16 The InkSpace Imaging Silhouette Adult Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MR |
| 00860008041340 - InkSpace Imaging Body Array | 2023-03-20 The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optim |
| 00860008041326 - Pediatric Body Array | 2022-02-18 The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to pro |