FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Ingenia 1.5T and Ingenia 1.5T S R5.2
K Number: K153324
·
Decision Mar 22, 2016
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
8
Review Days
125
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
- Ingenia 1.5T and Ingenia 1.5T S R5.2
- K Number
- K153324
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems Nederlands B.V.
- Date Received
- November 18, 2015
- Decision Date
- March 22, 2016
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNH), ordered by most recent decision date.
uMR Astra
FDA 510(k)
FDA Class 2
·Radiology
APERTO Lucent MRI System
FDA 510(k)
FDA Class 2
·Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
S-scan Open (100001800)
FDA 510(k)
FDA Class 2
·Radiology
nordicAudio (1.0)
FDA 510(k)
FDA Class 2
·Radiology
Embrace Neonatal MRI System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Philips Medical Systems Nederlands B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K240224 | Zenition 90 | May 22, 2024 | Substantially Equivalent |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | Dec 23, 2022 | Substantially Equivalent |
| K201743 | ClarifEye R1.0, ClarifEye Needle | Feb 23, 2021 | Substantially Equivalent |
| K181311 | Philips Hemodynamic Application R1.0 | Sep 7, 2018 | Substantially Equivalent |
| K181966 | SmartPerfusion | Aug 17, 2018 | Substantially Equivalent |
| K162025 | IntelliSpace Portal Platform | Oct 18, 2016 | Substantially Equivalent |
| K143128 | mDIXON XD | Mar 20, 2015 | Substantially Equivalent |