Identity
- Trade Name
- Portable Dental X-ray (CS 2300P) FDA UDI
- Generic Name
- Hand-held intraoral dental x-ray system, digital FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- NP-350E FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800072313310 FDA UDI
- 510(k) Number
- K201800 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Hand-held intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held intraoral dental x-ray system, digital
Portable Dental X-ray (CS 2300P) by Nanoray Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K201800 also covers:
- Portable Dental X-ray (CS 2400P) — NANORAY CO., LTD
- Portable Dental X-ray (NR-F350 with Back scatter shield) — NANORAY CO., LTD
- Portable Dental X-ray (NR-F350 without Back scatter shield) — NANORAY CO., LTD
- Portable Dental X-ray (R2 Port-X with Back scatter shield) — NANORAY CO., LTD
- Portable Dental X-ray (R2 Port-X without Back scatter shield) — NANORAY CO., LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nanoray Co., Ltd
Sources (2)
- FDA UDI 39df8fbf-2bd6-49af-9eda-089f6a3409ab 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026