FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Digital Wireless Intraoral X-Ray Sensor
K Number: K230998
·
Decision Oct 20, 2023
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
4
Review Days
196
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Digital Wireless Intraoral X-Ray Sensor
- K Number
- K230998
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iray Imaging Technology (Haining) Limited
- Date Received
- April 7, 2023
- Decision Date
- October 20, 2023
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUH), ordered by most recent decision date.
SOTA Cloud Smart Sensor (1.5)
FDA 510(k)
FDA Class 2
·Dental
EzSensor HD, EzSensor UHD
FDA 510(k)
FDA Class 2
·Dental
Cocoon Solo (DX-7020s)
FDA 510(k)
FDA Class 2
·Dental
Digital X-Ray DentiMax Pro Imaging System
FDA 510(k)
FDA Class 2
·Dental
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
FDA 510(k)
FDA Class 2
·Dental
X Sensor (Model: IOS-A15IF, HDI-15DGF)
FDA 510(k)
FDA Class 2
·Dental