FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DCX-100 CHEST UNIT-GL-5000M
K Number: K841923
·
Decision Aug 10, 1984
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
7
Review Days
92
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Basic Information
- Device Name
- DCX-100 CHEST UNIT-GL-5000M
- K Number
- K841923
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Transworld X-Ray Corp.
- Date Received
- May 10, 1984
- Decision Date
- August 10, 1984
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Transworld X-Ray Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K892657 | SENSIMAT | Jun 23, 1989 | Substantially Equivalent |
| K890066 | STAR 36 | Mar 28, 1989 | Substantially Equivalent |
| K873283 | MODEL C2-5000 OVERHEAD TUBE SUPPORT | Sep 10, 1987 | Substantially Equivalent |
| K872980 | MAM-CP X-RAY APPARATUS | Aug 27, 1987 | Substantially Equivalent |
| K872357 | TRANSWORLD 360V, MODEL A1-4040 | Jul 15, 1987 | Substantially Equivalent |
| K827582 | MODIFIED X-RAY TABLE | Jul 9, 1982 | Substantially Equivalent |