FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
K Number: K973953
·
Decision Jan 14, 1998
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
50
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
- K Number
- K973953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aktina Medical Physics Corp.
- Date Received
- October 16, 1997
- Decision Date
- January 14, 1998
- Product Code
- IXI
- 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 |
|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by Aktina Medical Physics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K103616 | PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER | Jan 25, 2011 | Substantially Equivalent |
| K081935 | STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 | Oct 7, 2008 | Substantially Equivalent |
| K040709 | PROTOS SOFTWARE | Apr 28, 2004 | Substantially Equivalent |
| K032248 | PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 | Sep 25, 2003 | Substantially Equivalent |
| K014081 | AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES | Mar 5, 2002 | Substantially Equivalent |
| K003330 | AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) | Jan 4, 2001 | Substantially Equivalent |
| K993522 | AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT | Jan 10, 2000 | Substantially Equivalent |
| K991546 | AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD | Jul 30, 1999 | Substantially Equivalent |
| K990997 | AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER | Jun 22, 1999 | Substantially Equivalent |
| K974239 | AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM | Feb 10, 1998 | Substantially Equivalent |