FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE NOMOS MINICRANE
K Number: K964740
·
Decision Feb 11, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
31
Applicant Total
21
Review Days
77
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Basic Information
- Device Name
- THE NOMOS MINICRANE
- K Number
- K964740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5770
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nomos Corp.
- Date Received
- November 26, 1996
- Decision Date
- February 11, 1997
- Product Code
- JAI
- 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 |
|---|---|---|---|
| JAI | Couch, Radiation Therapy, Powered | FDA class 2 | Radiology |
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| K993675 | PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM | Sep 5, 2000 | Substantially Equivalent |
| K993359 | RAPTOR TREATMENT PLANNING SYSTEM | Dec 21, 1999 | Substantially Equivalent |
| K991966 | THE NOMOS CHANE II | Sep 3, 1999 | Substantially Equivalent |
| K981424 | NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM | Jul 17, 1998 | Substantially Equivalent |
| K974310 | NOMOS SLIT COLLIMATOR (BEAK) | Feb 6, 1998 | Substantially Equivalent |