FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
K Number: K082104
·
Decision Sep 2, 2008
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
54
Review Days
39
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
- GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM
- K Number
- K082104
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Medical Systems, Inc.
- Date Received
- July 25, 2008
- Decision Date
- September 2, 2008
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 Ge Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091673 | GE LIGHTSPEED ACT FP16 | Jun 24, 2009 | Substantially Equivalent |
| K042844 | GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL | Nov 3, 2004 | Substantially Equivalent |
| K042053 | INNOVA 4100, INNOVA 3100 | Aug 26, 2004 | Substantially Equivalent |
| K040125 | SENOGRAPHIC STEREO | Apr 19, 2004 | Substantially Equivalent |
| K033244 | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION | Oct 16, 2003 | Substantially Equivalent |
| K031209 | GE 1.5T 8 CHANNEL TORSO COIL | May 23, 2003 | Substantially Equivalent |
| K023943 | CT COLONOGRAPHY | May 6, 2003 | Substantially Equivalent |
| K030934 | GE LOGIQ 9 MODEL 2375600 | Apr 17, 2003 | Substantially Equivalent |
| K030953 | GE 3.0T GENERAL PURPOSE FLEX COIL | Apr 10, 2003 | Substantially Equivalent |
| K030495 | 3.0T TORSO PHASED ARRAY COIL | Mar 5, 2003 | Substantially Equivalent |