FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MM-22 MICROTRON, MM50 MICROTRON
K Number: K900434
·
Decision Oct 23, 1990
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
7
Review Days
266
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Basic Information
- Device Name
- MM-22 MICROTRON, MM50 MICROTRON
- K Number
- K900434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Scanditronix, Inc.
- Date Received
- January 30, 1990
- Decision Date
- October 23, 1990
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Scanditronix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934303 | RFA A-300 | Aug 9, 1994 | Substantially Equivalent |
| K942092 | DPD-3 | Jul 29, 1994 | Substantially Equivalent |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | Jan 4, 1993 | Substantially Equivalent |
| K914926 | SCANDIPLAN - VERSION 338 | May 28, 1992 | Substantially Equivalent |
| K904753 | DIOLASE | Nov 9, 1990 | Substantially Equivalent |
| K843366 | SUPERPETT | Nov 21, 1984 | Substantially Equivalent |