FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMISONIC 4290
K Number: K791429
·
Decision Sep 21, 1979
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
13
Review Days
57
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
- EMISONIC 4290
- K Number
- K791429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Emi Medical, Inc.
- Date Received
- July 26, 1979
- Decision Date
- September 21, 1979
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.
ARTHUR
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow UW20
FDA 510(k)
FDA Class 2
·Radiology
Accuro XV
FDA 510(k)
FDA Class 2
·Radiology
QT Scanner 2000 Model A
FDA 510(k)
FDA Class 2
·Radiology
IntraSight Plus
FDA 510(k)
FDA Class 2
·Radiology
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Emi Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K781936 | SCANNER-EMI 7020 AND 7020R | Dec 4, 1978 | Substantially Equivalent |
| K781519 | EMI SIMULATOR REMOTE CONTROL CONSOLE | Sep 14, 1978 | Substantially Equivalent |
| K781051 | EMISONIC 4201 | Jul 17, 1978 | Substantially Equivalent |
| K780995 | COMPUTERIZED AXIAL TOMOGRAPHY | Jun 22, 1978 | Substantially Equivalent |
| K780928 | CT5137 HIGH RESOLUTION OPTION | Jun 14, 1978 | Substantially Equivalent |
| K780930 | 5543 INDEPENDENT VIEWING SYSTEM | Jun 14, 1978 | Substantially Equivalent |
| K780737 | CT BLANKETS (BOLUS MATERIAL) | Jun 2, 1978 | Substantially Equivalent |
| K780736 | CT 5221 DOSE REDUCING COLLIMATORS | Jun 2, 1978 | Substantially Equivalent |
| K771978 | CTR 100L | Nov 23, 1977 | Substantially Equivalent |
| K772125 | TOMOGRAPHIC SCANNER, COMPUTERIZED | Nov 21, 1977 | Substantially Equivalent |