inkspaceimaging.comInkSpace Imaging Small Body Array
Inkspace Imaging, Inc.
INKSPACE IMAGING, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021244844 | 3021244844 | INKSPACE IMAGING, INC | 1 | N | 2026-01-01 | 5635 West Las Positas Blvd, Suite 403/404 Pleasanton CA US 94588 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860008041326 | Pediatric Body Array - The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy. | 925-425-7411 | my.nguyen@inkspaceimaging.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 300857 | 1777673012 | K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | MOS | 2025-10-20 |
| 300857 | 1643471332 | K243675 | InkSpace Imaging Small Body Array | MOS | 2024-12-20 |
| 300857 | 1778496442 | K233444 | InkSpace Imaging Small Body Array | MOS | 2024-01-08 |
| 300857 | 1637991542 | K223487 | InkSpace Imaging Body Array | MOS | 2022-12-08 |
| 300857 | 1111236326 | K213397 | InkSpace Imaging Pediatric Body Array | MOS | 2021-12-17 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MOS | 5 | 2025-10-20 |
PMN#
InkSpace Imaging Small Body Array
Inkspace Imaging, Inc.
InkSpace Imaging Body Array
InkSpace Imaging, Inc.
InkSpace Imaging Pediatric Body Array
InkSpace Imaging, Inc.
GUDID#
Nuzzle Body Array, 1.5T - The InkSpace Imaging Nuzzle Body 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 whimsical bird design is designed to help reduce anxiety during the MR scan.
2026-04-21
Silhouette Body Array – PH 3T (Cherry Blossoms) - The InkSpace Imaging Silhouette Body Array is a phased array, receive-only coil designed to work on Philips 3.0 Tesla (3.0T) MRI scanners. It consists of 12 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. The cherry blossom cover is designed to help reduce anxiety during the MR scan.
2026-04-21
Snuggle Pediatric Array – PH 3T (Dino) - The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Philips 3.0 Tesla (3.0T) MRI scanners. It consists of 12 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. The space dinosaur theme is child friendly and designed to help reduce anxiety during the MR scan.
2026-04-21
Nuzzle Body Array – PH 3T (Whimsical) - The InkSpace Imaging Nuzzle Body Array is a phased array, receive-only coil designed to work on Philips 3.0 Tesla (3.0T) MRI scanners. It consists of 12 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. The whimsical birds cover is designed to help reduce anxiety during the MR scan.
2026-04-21
Snuggle Pediatric Array, 1.5T - The 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.
2026-01-22
Silhouette Body Array, 1.5T - The InkSpace Imaging Silhouette Body 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.
2026-01-22
Pediatric Body Array - The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.
2022-02-10
Snuggle Pediatric Array - The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on GE 3.0 Tesla (3.0T) 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.
2024-11-25
Nuzzle Veterinary Array - The InkSpace Imaging Nuzzle Veterinary Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) 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.
2024-11-25
Snuggle Pediatric Array - The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) 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.
2024-02-08
Silhouette Adult Array - The InkSpace Imaging Silhouette Adult Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) 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.
2024-02-08
InkSpace Imaging Body Array - The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Body Array were designed specifically to fit body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.
2023-03-10