FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
K Number: K982937
·
Decision Nov 19, 1998
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
40
Review Days
90
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Basic Information
- Device Name
- MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
- K Number
- K982937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Victoreen, Inc.
- Date Received
- August 21, 1998
- Decision Date
- November 19, 1998
- Product Code
- LHN
- 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 |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
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Other Clearances by Victoreen, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K934549 | ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD | Feb 19, 1994 | Substantially Equivalent |