FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
ACHILLES
K Number: K123238
·
Decision Feb 25, 2013
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
8
Applicant Total
12
Review Days
132
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
- ACHILLES
- K Number
- K123238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1180
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems China Co., Ltd.
- Date Received
- October 16, 2012
- Decision Date
- February 25, 2013
- Product Code
- MUA
- 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 |
|---|---|---|---|
| MUA | Bone Sonometer | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUA), ordered by most recent decision date.
Bindex BI-2
FDA 510(k)
FDA Class 2
·Radiology
EchoS Family
FDA 510(k)
FDA Class 2
·Radiology
EchoS
FDA 510(k)
FDA Class 2
·Radiology
UltraScan 650
FDA 510(k)
FDA Class 2
·Radiology
Bindex BI-2
FDA 510(k)
FDA Class 2
·Radiology
Bindex BI-100
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Ge Medical Systems China Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K151063 | Monitor B40 | Dec 15, 2015 | Substantially Equivalent |
| K142288 | MAC 800 Resting ECG Analysis System | Dec 3, 2014 | Substantially Equivalent |
| K133576 | MONITOR B40 | Feb 21, 2014 | Substantially Equivalent |
| K130584 | MONITOR B40 | Jun 26, 2013 | Substantially Equivalent |
| K122253 | PROCARE MONITOR B20 | Mar 22, 2013 | Substantially Equivalent |
| K120598 | PROCARE MONITOR B40 | Jul 19, 2012 | Substantially Equivalent |
| K103633 | ACHILLES | May 11, 2011 | Substantially Equivalent |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | Oct 5, 2010 | Substantially Equivalent |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Aug 12, 2010 | Substantially Equivalent |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | May 26, 2009 | Substantially Equivalent |