FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K Number: K061608
·
Decision Nov 22, 2006
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
11
Review Days
166
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
- MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
- K Number
- K061608
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Medical Corp.
- Date Received
- June 9, 2006
- Decision Date
- November 22, 2006
- Product Code
- IYN
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYN), ordered by most recent decision date.
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ES-Series
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
LOGIQ e
FDA 510(k)
FDA Class 2
·Radiology
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Hitachi Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K073310 | OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL | Jan 18, 2008 | Substantially Equivalent |
| K053258 | EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Dec 9, 2005 | Substantially Equivalent |
| K042501 | ETG-4000 OPTICAL TOPOGRAPHY SYSTEM | Oct 12, 2004 | Substantially Equivalent |
| K013722 | MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 11, 2002 | Substantially Equivalent |
| K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 6, 2002 | Substantially Equivalent |
| K012239 | MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM | Aug 10, 2001 | Substantially Equivalent |
| K011252 | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM | May 30, 2001 | Substantially Equivalent |
| K926209 | EUB-555 | Jun 3, 1994 | Substantially Equivalent |
| K910268 | TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T | Apr 15, 1991 | Substantially Equivalent |
| K827377 | MODEL LS 3000 LINEAR SCANNER | Jul 13, 1982 | Substantially Equivalent |