FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECTRA ORTHOPEDIC PACKAGE
K Number: K031590
·
Decision Oct 2, 2003
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
9
Review Days
134
Basic Information
- Device Name
- SECTRA ORTHOPEDIC PACKAGE
- K Number
- K031590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SECTRA-IMTEC AB
- Date Received
- May 21, 2003
- Decision Date
- October 2, 2003
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by SECTRA-IMTEC AB
| K Number | Device Name | ||
|---|---|---|---|
| K040376 | SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE | May 4, 2004 | Substantially Equivalent |
| K033712 | MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 | Dec 23, 2003 | Substantially Equivalent |
| K021527 | SECTRA OSTEOPOROSIS PACKAGE | Jun 7, 2002 | Substantially Equivalent |
| K002936 | MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM | Oct 17, 2000 | Substantially Equivalent |
| K983447 | WISE (II) IMAGE MANAGEMENT SYSTEM | Oct 29, 1998 | Substantially Equivalent |
| K965161 | SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) | Mar 12, 1997 | Substantially Equivalent |
| K963395 | IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM | Oct 25, 1996 | Substantially Equivalent |
| K961983 | TRS 2000 TELERADIOLOGY SYSTEM | Aug 13, 1996 | Substantially Equivalent |