FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
IMPAX OT3000 ORTHOPEDIC WORKSTATION
K Number: K040344
·
Decision May 12, 2004
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
19
Review Days
90
Basic Information
- Device Name
- IMPAX OT3000 ORTHOPEDIC WORKSTATION
- K Number
- K040344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AGFA CORP.
- Date Received
- February 12, 2004
- Decision Date
- May 12, 2004
- 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 AGFA CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K063421 | DX-SI | Nov 22, 2006 | Substantially Equivalent |
| K053458 | WEB1000 | Dec 22, 2005 | Substantially Equivalent |
| K050810 | AGFA CR50.0 | Apr 21, 2005 | Substantially Equivalent |
| K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X | Apr 21, 2005 | Substantially Equivalent |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | Oct 21, 2004 | Substantially Equivalent |
| K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | Jul 22, 2004 | Substantially Equivalent |
| K040555 | IMPAX CLIENT EMBRACE | May 26, 2004 | Substantially Equivalent |
| K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 | Sep 24, 2003 | Substantially Equivalent |
| K023287 | DRYSTAR 5500 | Oct 22, 2002 | Substantially Equivalent |
| K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE | Sep 26, 2002 | Substantially Equivalent |