FDA.reportPublic FDA data

Owandy-RX DC

Primary DI
03760262653013
Brand
Owandy-RX DC
Company
OWANDY RADIOLOGY
Model
DC OWANDY 115V,SHORT CONE,BOTT 110 (16” - 40,64cm)
Catalog number
5.92.15603
Device description
Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231055000x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L.2023-12-28EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262653013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262653013037602626530133760262653013

GMDN Terms#

Term, Definition table
TermDefinition
Stationary intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure85 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure85 KiloPascal106 KiloPascal
Storage Environment Humidity25 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
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
03760262650647Owandy-RX PROOWANDY-RX PRO TOP 80 SHORT CONE, INTERF WALL PLATEW08060012022-10-07

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Primary DI, Brand, Company table
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D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
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08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
D7641000083061XIOS AESIRONA DENTAL, INC.EHD2019-06-06
D7641000081680XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000081790XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000083480XIOS AESIRONA DENTAL, INC.EHD2019-06-05
08800040900047POSKOM Co., Ltd.Poskom Co., Ltd.EHD2018-06-19
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