FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
hyperion X5, NewTom GO, X-RADiUS COMPACT
K Number: K200688
·
Decision Apr 9, 2020
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
21
Review Days
24
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Basic Information
- Device Name
- hyperion X5, NewTom GO, X-RADiUS COMPACT
- K Number
- K200688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cefla S.C.
- Date Received
- March 16, 2020
- Decision Date
- April 9, 2020
- Product Code
- OAS
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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Other Clearances by Cefla S.C.
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|---|---|---|---|
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| 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 |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Apr 24, 2019 | Substantially Equivalent |
| K183448 | NewTom 5G XL | Mar 8, 2019 | Substantially Equivalent |