FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FULL FRAME ZOOM SYSTEM
K Number: K961193
·
Decision Jun 17, 1996
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
20
Review Days
88
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Basic Information
- Device Name
- FULL FRAME ZOOM SYSTEM
- K Number
- K961193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Xre Corp.
- Date Received
- March 21, 1996
- Decision Date
- June 17, 1996
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Xre Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973744 | UNICATH SP BI-PLANE (MODEL M269 & M289) | Dec 29, 1997 | Substantially Equivalent |
| K960998 | XRE COLLIMATOR | Apr 3, 1996 | Substantially Equivalent |
| K945449 | UNICATH LLU ANGIOGRAPHIC SYSTEM | Feb 27, 1995 | Substantially Equivalent |
| K936002 | CINEMAC QAS | Sep 9, 1994 | Substantially Equivalent |
| K933460 | DVFX, MODEL M256 | Apr 7, 1994 | Substantially Equivalent |
| K924828 | BI-N | Dec 17, 1992 | Substantially Equivalent |
| K923654 | POLY DIAGNOST CDX | Nov 20, 1992 | Substantially Equivalent |
| K913685 | UNICATH EP. | Nov 7, 1991 | Substantially Equivalent |
| K912416 | ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM | Aug 28, 1991 | Substantially Equivalent |
| K892849 | UNICATH A | Aug 9, 1989 | Substantially Equivalent |