FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR
K Number: K851440
·
Decision Jun 5, 1985
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
20
Applicant Total
6
Review Days
56
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Basic Information
- Device Name
- RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR
- K Number
- K851440
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1880
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Summit Industries, Inc.
- Date Received
- April 10, 1985
- Decision Date
- June 5, 1985
- 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 |
Similar 510(k) Clearances
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Other Clearances by Summit Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874908 | C900 X-RAY FILM PROCESSOR | Feb 12, 1988 | Substantially Equivalent |
| K874687 | COLLI-MATETM MODEL NO. B800 | Dec 30, 1987 | Substantially Equivalent |
| K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG | May 14, 1985 | Substantially Equivalent |
| K850117 | XMA 325 (X-RAY GENERATOR) | Apr 9, 1985 | Substantially Equivalent |
| K850118 | XMA INTEGRATED TABLE | Apr 9, 1985 | Substantially Equivalent |