FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI DIAGNOST
K Number: K874113
·
Decision Nov 16, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
20
Review Days
38
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Basic Information
- Device Name
- OMNI DIAGNOST
- K Number
- K874113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Xre Corp.
- Date Received
- October 9, 1987
- Decision Date
- November 16, 1987
- Product Code
- IXR
- 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IXR), ordered by most recent decision date.
VISION R/F TILTING TABLE
FDA 510(k)
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·Radiology
LEGACY/LEGACY-D TABLE
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FDA Class 2
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CAP-35B III/CINE 275
FDA 510(k)
FDA Class 2
·Radiology
PHILIPS EASY DIAGNOST
FDA 510(k)
FDA Class 2
·Radiology
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
FDA 510(k)
FDA Class 2
·Radiology
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Xre Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973744 | UNICATH SP BI-PLANE (MODEL M269 & M289) | Dec 29, 1997 | Substantially Equivalent |
| K961193 | FULL FRAME ZOOM SYSTEM | Jun 17, 1996 | 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 |