FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
K Number: K032635
·
Decision Sep 24, 2003
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
19
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
- K Number
- K032635
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2040
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agfa Corp.
- Date Received
- August 26, 2003
- Decision Date
- September 24, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMC), ordered by most recent decision date.
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
FDA 510(k)
FDA Class 2
·Radiology
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
FDA 510(k)
FDA Class 2
·Radiology
DRYVIEW CHROMA IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CYPHER DICOM PRINT SOLUTION
FDA 510(k)
FDA Class 2
·Radiology
CARESTREAM DRYVIEW 5850 LASER IMAGER
FDA 510(k)
FDA Class 2
·Radiology
SONY UP-DF750 DIGITAL FILM IMAGER
FDA 510(k)
FDA Class 2
·Radiology
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 |
| 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 |
| 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 |