FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CT/MRI TOPOGRAPHIC MARKER
K Number: K930752
·
Decision Nov 19, 1993
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
17
Applicant Total
7
Review Days
280
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Basic Information
- Device Name
- CT/MRI TOPOGRAPHIC MARKER
- K Number
- K930752
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1640
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- I.Z.I. Corp.
- Date Received
- February 12, 1993
- Decision Date
- November 19, 1993
- Product Code
- JAC
- 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 |
|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | FDA class 1 | 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 |
| K922287 | E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS | Oct 16, 1992 | Substantially Equivalent |