FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-125 RAPID STRAND
K Number: K940632
·
Decision Sep 2, 1994
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
9
Review Days
200
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Basic Information
- Device Name
- I-125 RAPID STRAND
- K Number
- K940632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Date Received
- February 14, 1994
- Decision Date
- September 2, 1994
- Product Code
- IWI
- 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 |
|---|---|---|---|
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IWI), ordered by most recent decision date.
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
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PALLADIUM SEED MODEL 100
FDA 510(k)
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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 |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | Jul 1, 1992 | 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 |