FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
K Number: K013723
·
Decision Feb 6, 2002
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
11
Review Days
89
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-6500 DIAGNOSTIC ULTRASOUND SCANNER
- K Number
- K013723
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Medical Corp.
- Date Received
- November 9, 2001
- Decision Date
- February 6, 2002
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
FDA 510(k)
FDA Class 2
·Radiology
Mendaera Guidance System
FDA 510(k)
FDA Class 2
·Radiology
Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
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 |
| K061608 | MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER | Nov 22, 2006 | 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 |
| 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 |