FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRA-OPERATIVE ULTRASOUND TRANSDUCER
K Number: K140854
·
Decision Jun 11, 2014
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
6
Review Days
69
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
- INTRA-OPERATIVE ULTRASOUND TRANSDUCER
- K Number
- K140854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Aloka Medical, Ltd.
- Date Received
- April 3, 2014
- Decision Date
- June 11, 2014
- 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 Aloka Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | Jan 14, 2015 | Substantially Equivalent |
| K140639 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 16, 2014 | Substantially Equivalent |
| K130308 | NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM | Apr 5, 2013 | Substantially Equivalent |
| K123828 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 18, 2013 | Substantially Equivalent |
| K122341 | PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 | Sep 26, 2012 | Substantially Equivalent |