FDA.reportPublic FDA data

P-81

Primary DI
04560141949300
Brand
P-81
Company
KONICA MINOLTA, INC.
Model
ADA7
Published
2022-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172793000SKR 3000Konica Minolta, Inc.2017-10-12MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560141949300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560141949300045601419493004560141949300

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
692076161
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560141951471ImagePilotV1.96R01E2026-04-24
04560141947719KONICAMINOLTA DI-X1AD1D2026-03-25
04560141950887P-53AEA02024-12-06
04560141950894P-53AEA12024-12-06
04560141945753P-61A8CE2017-01-04
04560141945821P-61A9YC2017-01-04
04560141950665DRYPRO SD-QM2AE6G2025-05-22
04560141950672DRYPRO SD-QM2AE6H2025-05-22
04560141950689DRYPRO SD-QM2AE6J2025-05-22
04560141951426CS-7AEVE2025-04-14
04560141951419CS-7AEVD2024-12-06
04560141951914KONICAMINOLTA DI-X1AEYC2024-10-07
04560141921788REGIUS MODEL 110JFF72016-09-19
04560141925557REGIUS MODEL 210A1YD2016-09-19
04560141925564REGIUS MODEL 110HQA1YC2016-09-19
04560141933170REGIUS MODEL SIGMAA1P62016-09-19
04560141933194REGIUS MODEL SIGMAA1P82016-09-19
04560141936379REGIUS MODEL SIGMA2A5ER2016-09-19
04560141936393REGIUS MODEL SIGMA2A5ET2016-09-19
04560141936423REGIUS MODEL SIGMA2A5EU2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
D0031000082900SchickDentsply International Inc.MQB2024-11-06
D0031000085860SchickDentsply International Inc.MQB2024-11-06
D0031000085870SchickDentsply International Inc.MQB2024-11-06
D0031000085880SchickDentsply International Inc.MQB2024-11-06
D0031000086260SchickDentsply International Inc.MQB2024-11-06
D0031000086300SchickDentsply International Inc.MQB2024-11-06
D0031000086350SchickDentsply International Inc.MQB2024-11-06
D0031000086360SchickDentsply International Inc.MQB2024-11-06
D0031000086380SchickDentsply International Inc.MQB2024-11-06
D0031000086390SchickDentsply International Inc.MQB2024-11-06
D0031000086410SchickDentsply International Inc.MQB2024-11-06
D0031000086520SchickDentsply International Inc.MQB2024-11-06
D0031000086530SchickDentsply International Inc.MQB2024-11-06
D0031000086540SchickDentsply International Inc.MQB2024-11-06