FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS
K Number: K922287
·
Decision Oct 16, 1992
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
7
Review Days
154
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Basic Information
- Device Name
- E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS
- K Number
- K922287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- I.Z.I. Corp.
- Date Received
- May 15, 1992
- Decision Date
- October 16, 1992
- Product Code
- KPQ
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by I.Z.I. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K022074 | SPHERZ | Aug 13, 2002 | Substantially Equivalent |
| K014022 | MRI LINE MARKER | Mar 4, 2002 | Substantially Equivalent |
| K003736 | MRI LINE MARKER | Jan 18, 2001 | Substantially Equivalent |
| K994117 | MR ENHANCER | Feb 4, 2000 | Substantially Equivalent |
| K993742 | SUPER TISSUE | Feb 2, 2000 | Substantially Equivalent |
| K930752 | CT/MRI TOPOGRAPHIC MARKER | Nov 19, 1993 | Substantially Equivalent |