FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.
K Number: K800998
·
Decision May 28, 1980
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
14
Review Days
33
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Basic Information
- Device Name
- ATLAS-S X-RAY SYSTEM W/KETROMAT GEN.
- K Number
- K800998
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- General X-Ray, Inc.
- Date Received
- April 25, 1980
- Decision Date
- May 28, 1980
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by General X-Ray, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K790511 | MOBILE 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 |