FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CS2000 & CS2000 TOMO
K Number: K973834
·
Decision Apr 30, 1998
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
8
Review Days
204
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Basic Information
- Device Name
- CS2000 & CS2000 TOMO
- K Number
- K973834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pausch Corp.
- Date Received
- October 8, 1997
- Decision Date
- April 30, 1998
- Product Code
- IZF
- 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 |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | FDA class 2 | Radiology |
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Other Clearances by Pausch Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973864 | COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO | Jun 17, 1998 | Substantially Equivalent |
| K903395 | UROMAT 2000 | Aug 30, 1990 | Substantially Equivalent |
| K870856 | COSMOS | Mar 30, 1987 | Substantially Equivalent |
| K790742 | KS-78 VERTICAL WALL CASSETTE HOLDER | Apr 26, 1979 | Substantially Equivalent |
| K790740 | BS 66, UNIVERSAL BUCKY STAND | Apr 26, 1979 | Substantially Equivalent |
| K790741 | COMPACT SYSTEM | Apr 26, 1979 | Substantially Equivalent |
| K790743 | COORDINATUS, HORIZONTAL RADIOGRAPHOC | Apr 23, 1979 | Substantially Equivalent |