FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
K Number: K911501
·
Decision Jul 17, 1991
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
90
Review Days
105
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Basic Information
- Device Name
- SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
- K Number
- K911501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Shimadzu Medical Systems
- Date Received
- April 3, 1991
- Decision Date
- July 17, 1991
- 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 |
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| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Jul 27, 2006 | Substantially Equivalent |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | Jul 25, 2006 | Substantially Equivalent |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | Jul 14, 2006 | Substantially Equivalent |
| K052500 | DAR-8000F | Oct 17, 2005 | Substantially Equivalent |
| K052076 | DAR-8000I | Sep 2, 2005 | Substantially Equivalent |
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