FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
K Number: K901654
·
Decision Nov 23, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
5
Review Days
227
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Basic Information
- Device Name
- MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
- K Number
- K901654
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Imt America, Inc.
- Date Received
- April 10, 1990
- Decision Date
- November 23, 1990
- 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.
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ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
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·Radiology
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Imt America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903921 | MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE | Dec 4, 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 |