FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXIOM SIRESKOP SD
K Number: K051602
·
Decision Jul 7, 2005
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
25
Review Days
21
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
- AXIOM SIRESKOP SD
- K Number
- K051602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Systems, Inc.
- Date Received
- June 16, 2005
- Decision Date
- July 7, 2005
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAA), ordered by most recent decision date.
Nexus DRF Digital X-ray Imaging System
FDA 510(k)
FDA Class 2
·Radiology
Insight Enhanced DRF (EN-1002-01)
FDA 510(k)
FDA Class 2
·Radiology
Soteria E-View
FDA 510(k)
FDA Class 2
·Radiology
Adora DRFi (04550010)
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT Mobile Fluoroscopy System
FDA 510(k)
FDA Class 2
·Radiology
ProxiDiagnost N90 / Precision CRF (706110, 706400)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Siemens Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133646 | ADMIRE | Jun 20, 2014 | Substantially Equivalent |
| K130901 | SOMATOM DEFINITION AS OPEN | Jan 2, 2014 | Substantially Equivalent |
| K123540 | SYNGO CT PULMO 3D | Aug 29, 2013 | Substantially Equivalent |
| K123541 | SYNGO.CT NEURO PERFUSION | Apr 2, 2013 | Substantially Equivalent |
| K122909 | SYNGO SINGLE SOURCE DUAL ENGERY | Dec 27, 2012 | Substantially Equivalent |
| K122471 | SOMATOM DEFINITION | Sep 11, 2012 | Substantially Equivalent |
| K120579 | SOMATOM DEFINITION EDGE | May 23, 2012 | Substantially Equivalent |
| K121072 | SOMATOM DEFINITION FLASH | May 8, 2012 | Substantially Equivalent |
| K113342 | SOMATOM DEFINITION FLASH | Dec 29, 2011 | Substantially Equivalent |
| K052216 | SOMATOM DEFINITION | Sep 8, 2005 | Substantially Equivalent |