# RAYSCAN One Shot Ceph Small

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/rct700-option-one-shot-ceph>
- Manufacturer: [Ray Co., Ltd](https://devicerts.com/manufacturers/ray-co-ltd) (South Korea)
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: MUH, OAS
- EMDN: Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL
- GMDN: Stationary panoramic/tomographic dental x-ray system, digital (44245)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-08800003027033 · UDI-DI 08800003027033 · registered 2026-11-03 · status: Active
- **GUDID** · FDA 510(k) · United States · K260462 · decision 2026-04-09 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K251798 · decision 2025-11-25 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 08800003027033 · listed 2025-08-25 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K232325 · decision 2024-04-18 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K232287 · decision 2023-08-31 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K230753 · decision 2023-04-11 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K213226 · decision 2021-11-29 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: RAYSCAN [FDA GUDID (AccessGUDID)]
- Generic name: Stationary panoramic/tomographic dental x-ray system, digital [FDA GUDID (AccessGUDID)]
- Model / reference: One Shot Ceph(S) [EUDAMED]; RBS-AP03 [EUDAMED]; One Shot Ceph Small [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08800003027033 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-08800003027033 [EUDAMED]
- 510(k) Number: K213226 [FDA GUDID (AccessGUDID)]; K230753 [FDA GUDID (AccessGUDID)]; K232287 [FDA GUDID (AccessGUDID)]; K232325 [FDA GUDID (AccessGUDID)]; K251798 [FDA GUDID (AccessGUDID)]; K260462 [FDA GUDID (AccessGUDID)]
- FDA product code: MUH [FDA GUDID (AccessGUDID)]; OAS [FDA GUDID (AccessGUDID)]
- EMDN code: Z1103030102 [EUDAMED]
- GMDN term: Stationary panoramic/tomographic dental x-ray system, digital (44245) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 872.1800 [FDA GUDID (AccessGUDID)]; 892.1750 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: RAYSCAN One Shot Ceph Small, Ray Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/rct700-option-one-shot-ceph (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/rct700-option-one-shot-ceph.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/rct700-option-one-shot-ceph
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.