FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CTS SYSTEM
K Number: K941004
·
Decision Jul 29, 1994
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
39
Applicant Total
13
Review Days
150
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Basic Information
- Device Name
- CTS SYSTEM
- K Number
- K941004
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acoma Medical Imaging, Inc.
- Date Received
- March 1, 1994
- Decision Date
- July 29, 1994
- Product Code
- IYB
- 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | FDA class 1 | Radiology |
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Other Clearances by Acoma Medical Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981227 | SYMPHONY 360 REMOTE CONTROL TABLE | Jun 30, 1998 | Substantially Equivalent |
| K981131 | PATHFINDER MOBILE C ARM | Jun 26, 1998 | Substantially Equivalent |
| 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 |
| 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 |
| K900562 | TRANS X 100 CHEST FILM CHANGER | Apr 10, 1990 | Substantially Equivalent |