FDA.reportPublic FDA data

3543EZ CsI Digital Wireless Flat Panel Detector

Primary DI
00817100020285
Brand
3543EZ CsI Digital Wireless Flat Panel Detector
Company
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Model
PAN280
Device description
THL 3543EZ CsI Digital Wireless Flat Panel Detector-R
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817100020285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817100020285008171000202858171000202850817100020285

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-366-5343HTICSupport@konicaminolta.com

Regulatory Flags#

DUNS number
080269345
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817100021268KDR DDR Primary U Arm Primary2025-07-30
00817100020278KDR Floor Mount+ SystemKDR FMT+2026-01-08
00817100021282KDR Floor Mount SystemKDR FMT2026-01-08
00817100020360CR ReaderCR302016-09-24
00817100020391CR ReaderCRII602016-09-24
0081710002046910X12 Cassette for CR ReaderCASCR24302016-10-05
0081710002047614X17 Cassette for CR ReaderCASCR35432016-10-05
00817100020124Portable X-Ray SystemXR3102016-09-30
0081710002025414X17 Wireless GOS Flat Panel DetectorPAN2002016-09-24
00817100020315RF 14X17 Sensor PanelPAN2902016-09-24
00817100020483RF 11X14 Sensor PanelPAN2912016-10-06
00817100020513RF 11X14 Sensor PanelPAN2922017-04-30
00817100020193Konica Minolta SW (PACS) ExaEXA 01-04-0002016-09-24
00817100020209Konica Minolta SW (PACS) Opal Rad, 20/20 Opal RadOPAL 02-04-04-0002016-09-24
0081710002021617X17 CsI Fixed Flat Panel DetectorPAN2202016-09-24
0081710002022317X17 GOS Fixed Flat Panel DetectorPAN2212016-09-24
0081710002023014X17 Portable GOS Flat Panel DetectorPAN2402016-09-24
0081710002024714X17 Portable GOS Flat Panel Detector without USBPAN2412016-09-24
008171000202614343 CsI Digital Flat Panel DetectorPAN2602016-09-24
008171000203084143C CsI Compact Digital Flat Panel DetectorPAN2612016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
08800017000107DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000114DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000121DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
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08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
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00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
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