FDA.reportPublic FDA data

Panoura X-ERA

Primary DI
04547497759463
Brand
Panoura X-ERA
Company
YOSHIDA DENTAL MFG. CO., LTD., THE
Model
Panoura X-ERA MF C Type 1
Device description
Diagnostic imaging equipment for dental treatment. Panoramic, Cephalometric imaging(1 sensor type) & three-dimensional(3D, FOV size x 4) image.
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182198000Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.2019-01-31MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547497759463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547497759463045474977594634547497759463

GMDN Terms#

Term, Definition table
TermDefinition
Stationary panoramic/tomographic dental x-ray system, digitalA diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams used in advanced dental imaging applications involving the teeth, jaw, oral cavity, sinus, and/or other maxillofacial structures. It uses digital techniques for image capture, manipulation and display and may include various image processing and analysis capabilities. This system is designed with the capability to produce two or more special purpose dental x-ray examinations: linear scanning, panoramic, cephalometric, linear tomography, spiral tomography, scanograms.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0.7 KiloPascal1.06 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure0.7 KiloPascal1.6 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81336312165international-div@yoshida-net.co.jp
+81336312165yoshida4export-kokusai@yoshida-net.co.jp

Regulatory Flags#

DUNS number
690676978
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547497753058Mielscope +Floor Stand with Casters2025-09-01
04547497752334PreXion3DXP68UL2024-07-17
04547497771052Opelaser Opelaser PRO II2017-01-26
04547497771090OpelaserOpelaser Lite II2017-05-26
04547497757049PreXion3D EclipseXP772016-09-23
04547497771113MielscopeMielscope (Floor Stand with Casters)2023-11-28
04547497759456Panoura X-ERAPanoura X-ERA MF2019-05-10
04547497759470Panoura X-ERAPanoura X-ERA MF C Type 22019-05-10
04547497759517Panoura X-ERAPanoura X-ERA NF2019-05-10
04547497759524Panoura X-ERAPanoura X-ERA NF C Type 12019-05-10
04547497759531Panoura X-ERAPanoura X-ERA NF C Type 22019-05-10
04547497759050ImageWorks Panoura ImageWorks Panoura2016-10-13
04547497759067ImageWorks Panoura ImageWorks Panoura C2016-09-23
04547497759210ImageWorks PanouraImageWorks Panoura 3D2016-10-13
04547497759227ImageWorks PanouraImageWorks Panoura C 3D2016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01