FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARIETTA Prologue Diagnostic Ultrasound system and Transducers
K Number: K162902
·
Decision Dec 15, 2016
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
8
Review Days
59
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
- ARIETTA Prologue Diagnostic Ultrasound system and Transducers
- K Number
- K162902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi , Ltd.
- Date Received
- October 17, 2016
- Decision Date
- December 15, 2016
- 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 , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201042 | PROBEAT-CR | Jul 13, 2020 | Substantially Equivalent |
| K191801 | PROBEAT-CR | Sep 13, 2019 | Substantially Equivalent |
| K172087 | SANGRAY | Oct 27, 2017 | Substantially Equivalent |
| K163505 | ARIETTA PRECISION | May 30, 2017 | Substantially Equivalent |
| K162583 | ALOKA LISENDO 880 | Nov 17, 2016 | Substantially Equivalent |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | Jul 13, 2016 | Substantially Equivalent |
| K060834 | PROBEAT WITH MGCS | Apr 19, 2006 | Substantially Equivalent |