FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
K Number: K884555
·
Decision Feb 27, 1989
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
54
Review Days
119
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Basic Information
- Device Name
- TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
- K Number
- K884555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Toshiba Medical Systems
- Date Received
- October 31, 1988
- Decision Date
- February 27, 1989
- 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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Other Clearances by Toshiba Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K960948 | SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A | Dec 23, 1996 | Substantially Equivalent |
| K954310 | BLA-800A | Oct 18, 1995 | Substantially Equivalent |
| K954309 | ANGIOREX | Oct 6, 1995 | Substantially Equivalent |
| K893750 | MRT-50A MOBILE | Aug 9, 1989 | Substantially Equivalent |
| K891453 | DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V | Jun 1, 1989 | Substantially Equivalent |
| K890969 | TRANSESOPHAGEAL TRANSDUCER PEF-511SA | May 16, 1989 | Substantially Equivalent |
| K884788 | TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM | Feb 27, 1989 | Substantially Equivalent |
| K883359 | DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A | Jan 25, 1989 | Substantially Equivalent |
| K883756 | TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM | Nov 14, 1988 | Substantially Equivalent |
| K881305 | TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM | Oct 19, 1988 | Substantially Equivalent |