FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Myray- HYPERION X5
K Number: K152162
·
Decision Dec 24, 2015
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
21
Review Days
143
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
- Myray- HYPERION X5
- K Number
- K152162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cefla S.C.
- Date Received
- August 3, 2015
- Decision Date
- December 24, 2015
- 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
Other Clearances by Cefla S.C.
| K Number | Device Name | ||
|---|---|---|---|
| K260716 | Neowise | May 4, 2026 | Substantially Equivalent |
| K252353 | myray ProXIma X6 | Mar 10, 2026 | Substantially Equivalent |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Apr 1, 2024 | Substantially Equivalent |
| K231990 | Apex Locator | Feb 13, 2024 | Substantially Equivalent |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Jan 17, 2023 | Substantially Equivalent |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | May 9, 2022 | Substantially Equivalent |
| K220664 | NewTom 7G | May 6, 2022 | Substantially Equivalent |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Jan 20, 2022 | Substantially Equivalent |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACT | Apr 9, 2020 | Substantially Equivalent |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Apr 24, 2019 | Substantially Equivalent |