FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
K Number: K031631
·
Decision Jul 18, 2003
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
6
Review Days
52
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Basic Information
- Device Name
- STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
- K Number
- K031631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3D Line USA, Inc.
- Date Received
- May 27, 2003
- Decision Date
- July 18, 2003
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by 3D Line USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K034051 | DYNATRAC, COD. 50-1A | Apr 5, 2004 | Substantially Equivalent |
| K031281 | ERGO SRS | Dec 23, 2003 | Substantially Equivalent |
| K013535 | EVTOOL MODEL # V. 1.0 | Jan 18, 2002 | Substantially Equivalent |
| K011255 | 3D LINE STEROTACTIC HARDWARE ACCESSORIES | Dec 20, 2001 | Substantially Equivalent |
| K001163 | DMLC IV-ERGO | Oct 23, 2000 | Substantially Equivalent |