FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ablation Confirmation
K Number: K192427
·
Decision Oct 3, 2019
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
15
Review Days
28
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
- Ablation Confirmation
- K Number
- K192427
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuwave Medical, Inc.
- Date Received
- September 5, 2019
- Decision Date
- October 3, 2019
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
True Definition DL
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Neuwave Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232227 | ABLATE-IQ | Apr 4, 2024 | Substantially Equivalent |
| K231738 | NEUWAVE Microwave Ablation System and Accessories | Nov 16, 2023 | Substantially Equivalent |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | Aug 11, 2022 | Substantially Equivalent |
| K200081 | NEUWAVE Microwave Ablation System and Accessories | Nov 13, 2020 | Substantially Equivalent |
| K173756 | Certus 140 2.45GHz Ablation System | Oct 24, 2018 | Substantially Equivalent |
| K171022 | Ablation Confirmation | May 9, 2017 | Substantially Equivalent |
| K163118 | FLEX Microwave Ablation System and Accessories | Mar 9, 2017 | Substantially Equivalent |
| K161285 | Ablation Confirmation | Jun 29, 2016 | Substantially Equivalent |
| K160936 | Certus 140 2.45GHz Ablation System | May 4, 2016 | Substantially Equivalent |
| K150313 | Ablation Confirmation | Jul 9, 2015 | Substantially Equivalent |