FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANS X 100 CHEST FILM CHANGER
K Number: K900562
·
Decision Apr 10, 1990
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
13
Review Days
62
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Basic Information
- Device Name
- TRANS X 100 CHEST FILM CHANGER
- K Number
- K900562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Acoma Medical Imaging, Inc.
- Date Received
- February 7, 1990
- Decision Date
- April 10, 1990
- 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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|---|---|---|---|
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| K963851 | TILTING RADIOGRAPHIC TABLE (REMOTE) | Jan 23, 1997 | Substantially Equivalent |
| K944952 | ANGIOGRAPHIC SYSTEM | Feb 17, 1995 | Substantially Equivalent |
| K941017 | F/C/W TUBESTAND | Jul 29, 1994 | Substantially Equivalent |
| K941004 | CTS SYSTEM | Jul 29, 1994 | Substantially Equivalent |
| K925598 | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER | Feb 1, 1993 | Substantially Equivalent |
| K921116 | PX-100 PORTABLE X-RAY GENERATOR | Oct 5, 1992 | Substantially Equivalent |
| K921425 | SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R | Aug 27, 1992 | Substantially Equivalent |
| K902637 | FUTURUS 2001 X-RAY GENERATOR | Aug 3, 1990 | Substantially Equivalent |