FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
K Number: K972212
·
Decision Sep 10, 1997
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
91
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
- K Number
- K972212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ptw-New York Corp.
- Date Received
- June 12, 1997
- Decision Date
- September 10, 1997
- 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 Ptw-New York Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062817 | PTW DAVID IMRT QC VERIFICATION SYSTEM | Nov 22, 2006 | Substantially Equivalent |
| K010705 | OPTIDOS | Mar 11, 2003 | Substantially Equivalent |
| K010916 | PTW DOSIMETRY DIODE, T60008 | Jun 20, 2001 | Substantially Equivalent |
| K972211 | MULTIDOS, QC6PLUS | Sep 10, 1997 | Substantially Equivalent |
| K961208 | 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER | Jun 17, 1996 | Substantially Equivalent |
| K954165 | PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM | Dec 5, 1995 | Substantially Equivalent |
| K951764 | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR | Oct 7, 1995 | Substantially Equivalent |