FDA.reportPublic FDA data

FLAATZ

Primary DI
08800018403808
Brand
FLAATZ
Company
DRTECH Corporation
Model
FLAATZ 560
Device description
The FLAATZ 560 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitivephotoconductor.
Published
2016-09-02
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111583000FLAATZ 560Drtech Corp.2011-10-04MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018403808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018403808088000184038088800018403808

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging conversion systemAn assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689842626
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800018408209EXPD 4343SEXPD 4343S2026-03-17
08800018408308EXPD 4343DEXPD 4343D2026-03-17
08800018408407EXPD 3643DEXPD 3643D2026-03-17
08800018412008EConsole2EConsole22026-03-17
08800018424704XERO-alphaXERO α2026-03-17
08800018422601EXTRON 3EXTRON 32025-06-17
08800018430002EXPD-N seriesEXPD 4343N12025-06-13
08800018430101EXPD-N seriesEXPD 4343N2025-06-13
08800018430200EXPD-N seriesEXPD 4343U12025-06-13
08800018430309EXPD-N seriesEXPD 4343NU2025-06-13
08800018430408EXPD-N seriesEXPD 4343NP2025-06-13
08800018430507EXPD-N seriesEXPD 3643N12025-06-13
08800018430606EXPD-N seriesEXPD 3643N2025-06-13
08800018430705EXPD-N seriesEXPD 3643U12025-06-13
08800018430804EXPD-N seriesEXPD 3643NU2025-06-13
08800018430903EXPD-N seriesEXPD 3643NP2025-06-13
08800018420805EXTRON 5EXTRON 52023-08-24
08800018420904EXTRON 7EXTRON 72023-08-24
08800018408506EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PGEXPD 1142025-03-27
08800018408605EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PGEXPD 114G2025-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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