FDA.reportPublic FDA data

Nuzzle Body Array, 1.5T

Primary DI
00850083516000
Brand
Nuzzle Body Array, 1.5T
Company
Inkspace Imaging, Inc.
Model
SBA24SH15D
Device description
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.
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243675000InkSpace Imaging Small Body ArrayInkspace Imaging, Inc.2024-12-20MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083516000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083516000008500835160008500835160000850083516000

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

Regulatory Flags#

DUNS number
080330758
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)SBA12PH30B2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)SBA12PH30A2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)SBA12PH30C2026-04-21
00860008041364Snuggle Pediatric Array, 1.5TSBA24SH15B2026-01-22
00860008041388Silhouette Body Array, 1.5TSBA24SH15C2026-01-22
00860008041326Pediatric Body ArrayPBA24GE30A2022-02-10
00860008041333Snuggle Pediatric ArraySBA24GE30A2024-11-25
00860008041357Nuzzle Veterinary ArraySBA24SH30D2024-11-25
00860008041302Snuggle Pediatric ArraySBA24SH30B2024-02-08
00860008041319Silhouette Adult ArraySBA24SH30C2024-02-08
00860008041340InkSpace Imaging Body ArrayPBA24GE30B2023-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
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00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01
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00884838108080MRI CoilsPhilips Ds North America LLCMOS2025-09-30
00884838111172DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-09-30
00884838111189DunleePhilips Medical Systems Nederland B.V.MOS2025-09-30
00884838118980MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-09-30
00195278929518NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2025-09-26