FDA.reportPublic FDA data

I-MAX

Primary DI
03760262651620
Brand
I-MAX
Company
OWANDY RADIOLOGY
Model
I-MAX PAN CEPH 110-120V
Catalog number
9304201011
Device description
I-MAX CEPH version
Published
2021-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K203374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203374000X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)De Götzen S.R.L.2021-02-05MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262651620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262651620037602626516203760262651620

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 Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure63 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
265612235
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760262653006Owandy-RX DCDC OWANDY 115V,SHORT CONE,BOTT 80 (16” - 40,64cm)5.92.156022025-09-05
03760262653013Owandy-RX DCDC OWANDY 115V,SHORT CONE,BOTT 110 (16” - 40,64cm)5.92.156032025-09-05
03760262653020Owandy-RX DCDC OWANDY 115V,SHORT CONE,MOBILE5.92.156042025-09-05
03760262653044Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,BOTT 40 (16” - 40,645.92.156062025-09-05
03760262653051Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,BOTT 80 (16” - 40,645.92.156072025-09-05
03760262653068Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,BOTT 110 (16” - 40,65.92.156082025-09-05
03760262653075Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,MOBILE5.92.156092025-09-05
03760262653327Owandy-RX DCDC OWANDY 115V,SHORT CONE,NO BRACKET,NO WALL PLATE5.92.156852025-09-05
03760262653334Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,NO BRACKET,NO WALL P5.92.156902025-09-05
03760262653372Owandy-RX DCDC OWANDY 115V,SHORT CONE,TOP 40 (16” - 40,64cm)5.92.156102025-09-05
03760262653389Owandy-RX DCDC OWANDY 115V,SHORT CONE,TOP 80 (16” - 40,64cm)5.92.156112025-09-05
03760262653396Owandy-RX DCDC OWANDY 115V,SHORT CONE,TOP 110 (16” - 40,64cm)5.92.156122025-09-05
03760262653402Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,TOP 40 (16” - 40,64c5.92.156132025-09-05
03760262653419Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,TOP 80 (16” - 40,64c5.92.156142025-09-05
03760262653426Owandy-RX DCDC OWANDY 115V VET,SHORT CONE,TOP 110 (16” - 40,645.92.156152025-09-05
03760262652993Owandy-RX DCDC OWANDY 115V,SHORT CONE,BOTT 40 (16” - 40,64cm)5.92.156012025-09-04
03760262650814Owandy RadiologyOWANDY OPTEO SIZE 1.594581001502025-05-15
03760262651606I-MAXI-MAX PAN ONLY FLOOR 100-120V9304000011.FL2024-11-11
03760262651804I-MAX 3DI-MAX 3D PAN ONLY FLOOR 100-120V9304100011.FL2024-11-11
03760262650630Owandy-RX PROOWANDY-RX PRO TOP 40 SHORT CONE, INTERF WALL PLATEW08060002022-10-07

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