FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
K Number: K092004
·
Decision Aug 25, 2009
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
168
Review Days
54
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
- GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
- K Number
- K092004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Healthcare
- Date Received
- July 2, 2009
- Decision Date
- August 25, 2009
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OWB), ordered by most recent decision date.
C-beam
FDA 510(k)
FDA Class 2
·Radiology
Intelligent NR
FDA 510(k)
FDA Class 2
·Radiology
ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
FDA 510(k)
FDA Class 2
·Radiology
ARTIS genio floor; ARTIS icono.explore floor
FDA 510(k)
FDA Class 2
·Radiology
BELLIGER ACE
FDA 510(k)
FDA Class 2
·Radiology
Trinias
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by GE Healthcare
| K Number | Device Name | ||
|---|---|---|---|
| K253639 | View | Jan 8, 2026 | Substantially Equivalent |
| K242925 | MR Contour DL | Apr 1, 2025 | Substantially Equivalent |
| K232346 | Digital Expert Access with Remote Scanning | Oct 27, 2023 | Substantially Equivalent |
| K223212 | Precision DL | Apr 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 |