510(k) K023613
- Device
- AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
- Applicant
- Alphatek Corp.
- 510(k) number
- K023613
- Product code
- IXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-23
- Date received
- 2002-10-28
- Regulation
- 892.1900
- Classification name
- Processor, Radiographic-Film, Automatic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- PAUL M KUPSCO
- Address
- 2000 S. 25th Ave. Broadview IL US 60153 60153
FDA Registration Numbers#
- 3014150341
- 3003982003
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IXW#
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| K001321 | ALL-PRO 2010 | All-Pro Imaging Corp. | 2000-05-16 |
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| K991435 | AII-PRO 100 PLUS AND ALL-PRO 200 | All-Pro Imaging Corp. | 1999-05-20 |
| K981280 | CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS | Bayer Corp., Agfa Div. | 1998-04-30 |
| K973125 | MAMMOLOADER BY C.M.A. SRL | C.M.A. | 1997-10-08 |