FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEAD PLASTIC VIEWING PANELS
K Number: K850816
·
Decision Apr 10, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
6
Applicant Total
40
Review Days
41
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Basic Information
- Device Name
- LEAD PLASTIC VIEWING PANELS
- K Number
- K850816
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Victoreen, Inc.
- Date Received
- February 28, 1985
- Decision Date
- April 10, 1985
- Product Code
- EAK
- 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 |
|---|---|---|---|
| EAK | Screen, Leaded, Operator Radiation Protector | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EAK), ordered by most recent decision date.
CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628
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ED CORP RADIATION SCREEN
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MULTIPLE ED1600 SERIES RADIATION SHIELDS
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MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
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CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
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MODULAR X-RAY BARRIERS
FDA 510(k)
FDA Class 1
·Radiology
Other Clearances by Victoreen, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982937 | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER | Nov 19, 1998 | Substantially Equivalent |
| K974112 | VACUDAP, MODEL 2000, 2001 | Jan 29, 1998 | Substantially Equivalent |
| K973960 | MODEL 37-185 | Jan 14, 1998 | Substantially Equivalent |
| K964952 | VERIDOSE V (FIVE), MODEL NUMBER 37-705 | Jul 21, 1997 | Substantially Equivalent |
| K964785 | VERIDOSE DIODES | Jun 13, 1997 | Substantially Equivalent |
| K971382 | PRONE BREAST POSITIONING BOARD, MODEL #37-018 | Jun 6, 1997 | Substantially Equivalent |
| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Jun 16, 1995 | Substantially Equivalent |
| K940660 | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM | Dec 9, 1994 | Substantially Equivalent |
| K935435 | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST | Jul 29, 1994 | Substantially Equivalent |
| K941931 | DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR | May 26, 1994 | Substantially Equivalent |