NewTom 5G XL
FDA 510(k) K183448 · Cefla S.C.
510(k) numberK183448
Submission
- Device name
- NewTom 5G XL
- Applicant
- Cefla S.C.
Imola (Bo), IT - Received
- December 12, 2018
- Decision date
- March 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Siemens Medical Solutions USA, Inc.
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| K231990 | Apex LocatorLQY · Traditional | 02/13/2024SE |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special | 01/17/2023SE |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…EBW · Traditional | 05/09/2022SE |
| K220664 | NewTom 7GJAK · Traditional | 05/06/2022SE |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special | 01/20/2022SE |
| K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACTOAS · Traditional | 04/09/2020SE |
| K190496 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Traditional | 04/24/2019SE |
Questions and answers
When was NewTom 5G XL cleared by the FDA?
NewTom 5G XL (K183448) received a 510(k) decision of Substantially Equivalent on March 8, 2019, 86 days after the submission was received.
What is the product code of K183448?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.