FDA.reportPublic FDA data

Owandy Radiology

Primary DI
03760262652337
Brand
Owandy Radiology
Company
OWANDY RADIOLOGY
Model
Owandy-CR
Catalog number
9458900021
Device description
Owandy-CR V2 USB
Published
2020-02-20
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
K133271000
K143703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133271000OPTEO, VIDEOGRAPH HDOwandy2014-04-28MUH
K143703000NICAL SMART MICRO CR system for intraoral dental imagesNical Spa2015-03-18MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262652337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262652337037602626523373760262652337

GMDN Terms#

Term, Definition table
TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

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