FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
K Number: K913234
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
7
Review Days
63
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Basic Information
- Device Name
- VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
- K Number
- K913234
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Varian Canada, Inc.
- Date Received
- July 22, 1991
- Decision Date
- September 23, 1991
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Varian Canada, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953582 | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | Sep 26, 1995 | Substantially Equivalent |
| K923455 | HFG 350, 650, 1050 | Dec 28, 1992 | Substantially Equivalent |
| K920938 | VJW2919 PNEUMATIC COMPRESSION UPGRADE | Jun 17, 1992 | Substantially Equivalent |
| K910820 | VPW 2877E6 X-RAY POWER SUPPLY | Mar 7, 1991 | Substantially Equivalent |
| K904169 | VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY | Feb 19, 1991 | Substantially Equivalent |
| K905855 | VPW2877E7 X RAY POWER SUPPLY | Feb 13, 1991 | Substantially Equivalent |