FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARBON FIBER CONFORMAL COUCH TOP
K Number: K973842
·
Decision Dec 5, 1997
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
26
Applicant Total
41
Review Days
58
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Basic Information
- Device Name
- CARBON FIBER CONFORMAL COUCH TOP
- K Number
- K973842
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medtec, Inc.
- Date Received
- October 8, 1997
- Decision Date
- December 5, 1997
- Product Code
- IXQ
- 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 |
|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | FDA class 2 | Radiology |
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|---|---|---|---|
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| K093738 | MRI PATIENT POSITIONING DEVICES | May 14, 2010 | Substantially Equivalent |
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| K974700 | MATRIX MT-MX3 | Mar 4, 1998 | Substantially Equivalent |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Oct 1, 1996 | Substantially Equivalent |
| K955236 | GREEN TEC-2100 | May 24, 1996 | Substantially Equivalent |
| K954705 | ACRYSTEEL BLOCKING TRAY | Jan 5, 1996 | Substantially Equivalent |
| K954456 | THERMOPLASTIC SHIELD | Dec 21, 1995 | Substantially Equivalent |
| K954225 | MED-TEC HAND GRIP | Nov 14, 1995 | Substantially Equivalent |