FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE
K Number: K903921
·
Decision Dec 4, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
28
Applicant Total
5
Review Days
102
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Basic Information
- Device Name
- MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE
- K Number
- K903921
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Imt America, Inc.
- Date Received
- August 24, 1990
- Decision Date
- December 4, 1990
- Product Code
- IZZ
- 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 |
|---|---|---|---|
| IZZ | Table, Radiographic, Non-Tilting, Powered | FDA class 2 | Radiology |
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Other Clearances by Imt America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901654 | MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE | Nov 23, 1990 | Substantially Equivalent |
| K903422 | MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE | Sep 4, 1990 | Substantially Equivalent |
| K900193 | MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT | May 9, 1990 | Substantially Equivalent |
| K900194 | MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | May 7, 1990 | Substantially Equivalent |