FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
K Number: K982583
·
Decision Oct 5, 1998
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
49
Review Days
73
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
- SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
- K Number
- K982583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shimadzu Corp.
- Date Received
- July 24, 1998
- Decision Date
- October 5, 1998
- 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 Shimadzu Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Mar 6, 2015 | Substantially Equivalent |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | Mar 28, 2014 | Substantially Equivalent |
| K101039 | SHIMADZU COLLIMATOR R-300 | Sep 20, 2010 | Substantially Equivalent |
| K101036 | SHIMADZU COLLIMATOR R-20J | Aug 26, 2010 | Substantially Equivalent |
| K090578 | SHIMADZU COLLIMATOR R-30H | Nov 6, 2009 | Substantially Equivalent |
| K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | Jun 30, 2009 | Substantially Equivalent |
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | May 14, 2008 | Substantially Equivalent |
| K072006 | DAR-9400F | Aug 31, 2007 | Substantially Equivalent |
| K071717 | GE OEC ALTITUDE | Jul 5, 2007 | Substantially Equivalent |
| K062360 | BRANSIST SAFIRE | Oct 5, 2006 | Substantially Equivalent |