FDA.reportPublic FDA data

Portable Dental X-ray (CS 2400P)

Primary DI
08800072313228
Brand
Portable Dental X-ray (CS 2400P)
Company
NANORAY CO.,LTD
Model
NP-350E
Device description
Portable Dental X-ray (Model: NP-350E) is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is an X-ray device with a DC generator. The handheld device features a main unit (tube head), charger(cradle), and charger AC/DC power supply. The power is supplied by a rechargeable supercapacitor built into a device. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.
Published
2021-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K201800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201800000Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)Nanoray Co., Ltd.2020-12-28EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800072313228PackageGS11In Commercial Distribution
18800072313232PackageGS11In Commercial Distribution
08800072313211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800072313228088000723132288800072313228
1880007231323218800072313232
08800072313211088000723132118800072313211

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed 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. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure860 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82539624900service@nano-ray.com

Regulatory Flags#

DUNS number
695735177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800072313211Portable Dental X-ray (CS 2400P)NP-350E2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NP-350E2021-02-18
08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NP-350E2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NP-350E2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NP-350E2021-02-18
08800072313112Portable Dental X-ray (NR-F350 without Back scatter shield)NP-350E2021-02-18
08800072313327Portable Dental X-ray (CS 2300P)NP-350E2021-02-18
08800072313426Portable Dental X-ray (NR-F350 with Back scatter shield)NP-350E2021-02-18
08800072313525Portable Dental X-ray (R2 Port-X without Back scatter shield)NP-350E2021-02-18
08800072313624Portable Dental X-ray (R2 Port-X with Back scatter shield)NP-350E2021-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800021800168XTGDigiMed Co., Ltd.EHD2026-06-01
08800021800175XTG VDigiMed Co., Ltd.EHD2026-06-01
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
08800021800113xm-liteDigiMed Co., Ltd.EHD2022-12-01
08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NANORAY CO.,LTDEHD2021-02-18
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
D7641000064510Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10