FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONVEX PROBE, PVE-382M
K Number: K860281
·
Decision May 27, 1986
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
54
Review Days
119
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Basic Information
- Device Name
- CONVEX PROBE, PVE-382M
- K Number
- K860281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Toshiba Medical Systems
- Date Received
- January 28, 1986
- Decision Date
- May 27, 1986
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
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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 |
| K884555 | TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM | Feb 27, 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 |