FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IR-192 IMPLANT -- MODIFICATION
K Number: K923130
·
Decision Sep 21, 1992
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
7
Review Days
88
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Basic Information
- Device Name
- IR-192 IMPLANT -- MODIFICATION
- K Number
- K923130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Omnitron Intl., Inc.
- Date Received
- June 25, 1992
- Decision Date
- September 21, 1992
- Product Code
- KXK
- 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
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Other Clearances by Omnitron Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901615 | PULMOCATH INTRABRONCHIAL CATHETER | Nov 27, 1992 | Substantially Equivalent |
| K920431 | OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE | May 29, 1992 | Substantially Equivalent |
| K913908 | OMNITRON GYN APPLICATOR SYSTEM | Mar 6, 1992 | Substantially Equivalent |
| K915253 | IR-192 IMPLANT, MODIFICATION | Feb 27, 1992 | Substantially Equivalent |
| K911775 | OMNICATH IMPLANTED CATHETER AND DEPOT | May 8, 1991 | Substantially Equivalent |
| K881665 | OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR | Aug 11, 1988 | Substantially Equivalent |