FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOBILE X-RAY UNIT
K Number: K790511
·
Decision Mar 26, 1979
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
14
Review Days
10
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Basic Information
- Device Name
- MOBILE X-RAY UNIT
- K Number
- K790511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- General X-Ray, Inc.
- Date Received
- March 16, 1979
- Decision Date
- March 26, 1979
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by General X-Ray, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800998 | ATLAS-S X-RAY SYSTEM W/KETROMAT GEN. | May 28, 1980 | Substantially Equivalent |
| K790451 | X-RAY UNITS, GX-101, UCIS-510 AND GX-111 | Mar 28, 1979 | Substantially Equivalent |
| K790512 | PORTABLE X-RAY UNIT | Mar 26, 1979 | Substantially Equivalent |
| K790392 | 510 CARBINETTE X-RAY UNIT | Mar 26, 1979 | Substantially Equivalent |
| K790443 | PORTABLE X-RAY UNIT | Mar 26, 1979 | Substantially Equivalent |
| K790393 | PORTABLE X-RAY UNIT, MATRIX S GX-101 | Mar 26, 1979 | Substantially Equivalent |
| K781976 | MOBILE X-RAY UNIT | Dec 4, 1978 | Substantially Equivalent |
| K781675 | X-RAY COLLIMATOR | Dec 4, 1978 | Substantially Equivalent |
| K781975 | MOBILE CARRIER | Dec 4, 1978 | Substantially Equivalent |
| K781676 | X-RAY STAND, PORTABLE | Oct 17, 1978 | Substantially Equivalent |