FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
K Number: K991600
·
Decision Jun 9, 1999
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
66
Review Days
30
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
- SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
- K Number
- K991600
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Corp.
- Date Received
- May 10, 1999
- Decision Date
- June 9, 1999
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
True Definition DL
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Siemens Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL | Dec 17, 2010 | Substantially Equivalent |
| K993947 | KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY | Dec 21, 1999 | Substantially Equivalent |
| K992925 | AX WORKSTATION DR-VIEWER SOFTWARE OPTION | Nov 23, 1999 | Substantially Equivalent |
| K991652 | HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM | Aug 3, 1999 | Substantially Equivalent |
| K984221 | FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR | Feb 12, 1999 | Substantially Equivalent |
| K984224 | PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS | Feb 2, 1999 | Substantially Equivalent |
| K982536 | PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE | Nov 24, 1998 | Substantially Equivalent |
| K963983 | E. CAM PROFILE ATTENUATION CORRECTION | Mar 31, 1997 | Substantially Equivalent |
| K941546 | SOMATOM PROJECT 059 | Sep 20, 1994 | Substantially Equivalent |
| K942116 | SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER) | Jul 29, 1994 | Substantially Equivalent |