FDA.reportPublic FDA data

17X17 CsI Fixed Flat Panel Detector

Primary DI
00817100020216
Brand
17X17 CsI Fixed Flat Panel Detector
Company
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Model
PAN220
Device description
IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)
Published
2016-09-24
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
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
00817100020216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817100020216008171000202168171000202160817100020216

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 Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 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
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
008171000202853543EZ CsI Digital Wireless Flat Panel Detector PAN2802016-10-05
008171000203084143C CsI Compact Digital Flat Panel DetectorPAN2612016-09-24

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