FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SDMO APPLICATOR CODE: ASN.8236
K Number: K921961
·
Decision Jul 1, 1992
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
35
Applicant Total
9
Review Days
65
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Basic Information
- Device Name
- SDMO APPLICATOR CODE: ASN.8236
- K Number
- K921961
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Date Received
- April 27, 1992
- Decision Date
- July 1, 1992
- Product Code
- IWJ
- 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 |
|---|---|---|---|
| IWJ | System, Applicator, Radionuclide, Manual | FDA class 1 | Radiology |
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Other Clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging
| K Number | Device Name | ||
|---|---|---|---|
| K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 | Apr 11, 2001 | Substantially Equivalent |
| K940632 | I-125 RAPID STRAND | Sep 2, 1994 | Substantially Equivalent |
| K915156 | I-125 SEEDS CODE: 6702 | Jan 6, 1992 | Substantially Equivalent |
| K914268 | I-125 SEEDS IN CARRIER, CODE: 6720 | Nov 22, 1991 | Substantially Equivalent |
| K914281 | I-125 SEEDS, CODE: 6711 | Nov 22, 1991 | Substantially Equivalent |
| K811677 | KRYPTON CART | Jul 2, 1981 | Substantially Equivalent |
| K811688 | TUNGSTEN SYRINGE SHIELD | Jul 2, 1981 | Substantially Equivalent |
| K811118 | KRYPTON MASKS & TUBING | Jun 2, 1981 | Substantially Equivalent |