FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AGFA CR50.0
K Number: K050810
·
Decision Apr 21, 2005
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
19
Review Days
21
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Basic Information
- Device Name
- AGFA CR50.0
- K Number
- K050810
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agfa Corp.
- Date Received
- March 31, 2005
- Decision Date
- April 21, 2005
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 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 |
| 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 |
| K040344 | IMPAX OT3000 ORTHOPEDIC WORKSTATION | May 12, 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 |