FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XRT 600 R/F, WRF 0600
K Number: K992603
·
Decision Oct 25, 1999
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
9
Review Days
83
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Basic Information
- Device Name
- XRT 600 R/F, WRF 0600
- K Number
- K992603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wuestec Medical, Inc.
- Date Received
- August 3, 1999
- Decision Date
- October 25, 1999
- 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 Wuestec Medical, Inc.
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|---|---|---|---|
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| K981880 | DX-480, ADD ON DIGITAL IMAGER | Oct 20, 1998 | Substantially Equivalent |
| K974240 | LIGHTLINE-M | Dec 22, 1997 | Substantially Equivalent |
| K955414 | XRT 400 | Jul 24, 1996 | Substantially Equivalent |
| K960083 | MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 | Jul 24, 1996 | Substantially Equivalent |
| K935123 | SUPERSTAND 300 | Mar 27, 1996 | Substantially Equivalent |
| K933253 | SUPERSTAND 3000 | Aug 16, 1993 | Substantially Equivalent |