FDA.reportPublic FDA data

NA

Primary DI
00840682138130
Brand
NA
Company
USA INSTRUMENTS, INC.
Model
5432778
Published
2018-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KXHCradle, patient, radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXHCradle, Patient, RadiologicRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122174000PEDIATRIC POSITIONER PAD SETGe Healthcare Coils (Usa Instruments, Inc.)2012-11-16KXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682138130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682138130008406821381308406821381300840682138130

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804517571
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
001989530019981.5T AIR Posterior Array601510060151002025-12-10
00840682120050NA53914682016-08-01
00840682120067NA53928022016-08-01
00840682103732NA3.0T HD SHOULDER ARRAY24143312016-08-01
00840682103756NA3.0T HD BREAST ARRAY24155442016-08-01
00840682103763NA3.0T HD FLAT GEM TABLE BREAST ARRAY53974742016-08-01
00840682104487NA3.0T HD 8CH CTL ARRAY24155422016-08-01
00840682108560NA3.0T GEM RT Open Array2016-08-01
00840682108577NA3.0T GEM PVA53952552016-08-01
00840682108614NA3.0T 8CH HD TORSO ARRAY24154102016-08-01
00840682109741NA3.0T GEM HNU54450512016-08-01
00840682116473NA3.0T HD 8CH CARDIAC ARRAYU1-1004222016-08-01
00840682121033NACARDIAC ARRAY 1.5T 51546852016-08-01
00840682102483NA3.0T GEM Anterior Array53914542016-08-01
00840682104470NA3.0T HD NEUROVASCULAR ARRAY2016-08-01
00840682105095NA3.0T GEM PA53929302016-08-01
00840682108881NA3.0T AA55551672016-08-01
00840682114264NA3.0T 16CH HEAD NECK SPINE HNS ARRAY53413332016-08-01
00195278665249NA48CH HEAD COIL - 593010059301002023-08-03
00195278575814NA3.0T 16ch AIR AA58541012023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043319153Hyperfine Foam Back PadHyperfine Operations, Inc.KXH2026-05-26
07640178060753MultipadPearl Technology AGKXH2025-12-17
07640178060760PearlFitPearl Technology AGKXH2025-12-17
07640178060852PearlFitPearl Technology AGKXH2025-12-17
07640178060906PearlFitPearl Technology AGKXH2025-12-17
07640178060982ProFoamPearl Technology AGKXH2025-12-17
07640178060999ProFoamPearl Technology AGKXH2025-12-17
07640178061002ProFoamPearl Technology AGKXH2025-12-17
07640178061019ProFoamPearl Technology AGKXH2025-12-17
07640178061750ProFoamPearl Technology AGKXH2025-12-17
07640178061767ProFoamPearl Technology AGKXH2025-12-17
07640178061774ProFoamPearl Technology AGKXH2025-12-17
07640178061781ProFoamPearl Technology AGKXH2025-12-17
07640178061804ProBeltPearl Technology AGKXH2025-12-17
07640178061859ProFoamPearl Technology AGKXH2025-12-17
07640178061866ProFoamPearl Technology AGKXH2025-12-17
07640178061873ProFoamPearl Technology AGKXH2025-12-17
07640178061880ProFoamPearl Technology AGKXH2025-12-17
07640178061897ProBeltPearl Technology AGKXH2025-12-17
07640178061903ProFoamPearl Technology AGKXH2025-12-17
07640178061910ProFoamPearl Technology AGKXH2025-12-17
07640178062085ProFoamPearl Technology AGKXH2025-12-17
07640178062092ProFoamPearl Technology AGKXH2025-12-17
07640178062108ProFoamPearl Technology AGKXH2025-12-17
07640178062115ProFoamPearl Technology AGKXH2025-12-17
07640178062122ProFoamPearl Technology AGKXH2025-12-17
07640178062139ProFoamPearl Technology AGKXH2025-12-17
07640178062146ProFoamPearl Technology AGKXH2025-12-17
07640178062153ProFoamPearl Technology AGKXH2025-12-17
07640178062078pearltecPearl Technology AGKXH2025-07-28