FDA.reportPublic FDA data

AADCO

Primary DI
00840348526288
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
N-215
Catalog number
N-215
Device description
POSITION INDICATOR x-RAY MARKERS W/ INITIALS
Published
2022-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348526288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348526288008403485262888403485262880840348526288

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic image marker, manualAn object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.

Regulatory Flags#

DUNS number
153603204
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840348507690AADCOPB-505PB-5052022-12-14
00840348526493AADCON-640N-6402022-12-16
00840348526509AADCON-640DN-640D2022-12-16
00840348507409AADCOPB-200PB-2002022-12-07
00840348507416AADCOPB-201PB-2012022-12-07
00840348507454AADCOPB-206PB-2062022-12-07
00840348507461AADCOPB-207PB-2072022-12-07
00840348524185AADCOP-302P-3022022-12-07
00840348524192AADCOP-303P-3032022-12-07
00840348524208AADCOP-305P-3052022-12-07
00840348506396AADCOP-610P-6102022-12-14
00840348506402AADCOP-610CSP-610CS2022-12-14
00840348506419AADCOP-611P-6112022-12-14
00840348506426AADCOP-611CSP-611CS2022-12-14
00840348507997AADCOPBS-025PBS-0252022-12-14
00840348506259AADCOP-306P-3062022-12-07
00840348506709AADCOPB-121PB-1212022-12-07
00840348506716AADCOPB-121CPB-121C2022-12-07
00840348506723AADCOPB-122PB-1222022-12-07
00840348506730AADCOPB-122CPB-122C2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854810007007AirDRIcRco, Inc.MQB2026-07-22
00854810007014AirDRIcRco, Inc.MQB2026-07-22
00854810007120iDRIcRco, Inc.MQB2026-07-22
00854810007205AirDRIcRco, Inc.MQB2026-07-22
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
00198953056103DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00810035220546Radmedix AcuityDRe 1717tRADMEDIX, LLCMQB2025-10-28