FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO LR 5200 FILM RECORDER
K Number: K012010
·
Decision Sep 20, 2001
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
19
Review Days
85
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Basic Information
- Device Name
- MODIFICATION TO LR 5200 FILM RECORDER
- K Number
- K012010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agfa Corp.
- Date Received
- June 27, 2001
- Decision Date
- September 20, 2001
- Product Code
- LMC
- 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 |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
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| K050810 | AGFA CR50.0 | 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 |