FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY
K Number: K924445
·
Decision Feb 19, 1993
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
20
Applicant Total
9
Review Days
171
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Basic Information
- Device Name
- BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY
- K Number
- K924445
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1880
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Control-X, Inc.
- Date Received
- September 1, 1992
- Decision Date
- February 19, 1993
- Product Code
- IXY
- 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 |
|---|---|---|---|
| IXY | Holder, Radiographic Cassette, Wall-Mounted | FDA class 1 | Radiology |
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Other Clearances by Control-X, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952265 | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | Jul 6, 1995 | Substantially Equivalent |
| K920347 | TOP-X 650HF RADIOGRAPHIC X-RAY | May 17, 1993 | Substantially Equivalent |
| K920349 | PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR | Feb 12, 1993 | Substantially Equivalent |
| K920351 | PCX 650HF RADIOGRAPHIC X-RAY | Feb 12, 1993 | Substantially Equivalent |
| K924443 | RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE | Feb 5, 1993 | Substantially Equivalent |
| K924444 | B-4 FOUR-WAY RADIOGRAPHIC TABLE | Feb 5, 1993 | Substantially Equivalent |
| K913577 | MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR | Nov 5, 1991 | Substantially Equivalent |
| K913578 | MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR | Nov 1, 1991 | Substantially Equivalent |