FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Precision DL
K Number: K223212
·
Decision Apr 27, 2023
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
459
Applicant Total
47
Review Days
192
Basic Information
- Device Name
- Precision DL
- K Number
- K223212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1200
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Healthcare
- Date Received
- October 17, 2022
- Decision Date
- April 27, 2023
- Product Code
- KPS
- 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPS), ordered by most recent decision date.
Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
FDA 510(k)
FDA Class 2
·Radiology
Aurora
FDA 510(k)
FDA Class 2
·Radiology
HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
FDA 510(k)
FDA Class 2
·Radiology
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
FDA 510(k)
FDA Class 2
·Radiology
Aurora
FDA 510(k)
FDA Class 2
·Radiology
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by GE Healthcare
| K Number | Device Name | ||
|---|---|---|---|
| K232346 | Digital Expert Access with Remote Scanning | Oct 27, 2023 | Substantially Equivalent |
| K221680 | Xeleris V Processing and Review System | Mar 1, 2023 | Substantially Equivalent |
| K221932 | Omni Legend | Sep 2, 2022 | Substantially Equivalent |
| K213689 | Voluson P6, Voluson P8 | Feb 17, 2022 | Substantially Equivalent |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | Jan 13, 2022 | Substantially Equivalent |
| K211488 | LOGIQ E10 | Sep 10, 2021 | Substantially Equivalent |
| K211524 | LOGIQ E10s, LOGIQ Fortis | Aug 27, 2021 | Substantially Equivalent |
| K212004 | MyoSPECT, MyoSpect ES | Aug 27, 2021 | Substantially Equivalent |
| K211725 | Senographe Pristina | Aug 6, 2021 | Substantially Equivalent |
| K211215 | SenoBright HD | Jun 22, 2021 | Substantially Equivalent |