Afp 17 X 4 Automatic Film Processor
FDA 510(k) K925885 · Afp Imaging Corp.
510(k) numberK925885
Submission
- Device name
- Afp 17 X 4 Automatic Film Processor
- Applicant
- Afp Imaging Corp.
Elmsford, NY, US - Received
- November 16, 1992
- Decision date
- June 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IXW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111167 | Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintIXW · Traditional | Velopex International, Inc. | 08/18/2011SE |
| K093503 | Intrax Film ProcessorIXW · Traditional | Velopex International, Inc. | 01/06/2010SE |
| K091628 | Optimax, Compact 2, Optimax 2010, EcomaxIXW · Traditional | Protec GmbH & Co. KG | 08/21/2009SE |
| K024342 | Radiographic Film Processor, Models XP400 and XP1000IXW · Traditional | Daito Co., Ltd. | 04/23/2003SE |
| K023825 | Film Processor, Model Life Ray Pro 2500IXW · Abbreviated | S.A.I.E.P. S.R.L. | 02/12/2003SE |
| K023801 | Film Processor, Model Life Ray Pro 1000IXW · Abbreviated | S.A.I.E.P. S.R.L. | 02/12/2003SE |
| K023613 | AX200 Automatic X-Ray Film Processor, Model 6586.036IXW · Traditional | Alphatek Corp. | 01/23/2003SE |
| K022154 | Level 356 X-Ray Film Processor, Models MD & Md-DIXW · Traditional | Fischer Industries, Inc. | 09/30/2002SE |
| K002640 | Freedom Automatic Film ProcessorIXW · Abbreviated | J. Morita USA, Inc. | 11/08/2000SE |
| K002404 | Micro-Max, Model 319IXW · Traditional | Tek Marketing, Inc. | 08/30/2000SE |
More from Tek Marketing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123419 | Eva Select Digital Dental Imaging SystemMUH · Special | 12/27/2012SE |
| K072357 | Newtom VG Computed Tomography X-Ray SystemMUH · Special | 09/18/2007SE |
| K041120 | Ev Apan Digital, Model K1VSM2000MUH · Traditional | 08/30/2004SE |
| K030647 | Eva Digital Dental X-Ray SystemEHD · Special | 03/20/2003SE |
| K014144 | Extoral/Tescera Glazing Resin, Model T-1804EBF · Traditional | 02/07/2002SE |
| K013176 | Modification to: Sens-A-Ray System with Proimage SoftwareEHD · Special | 10/16/2001SE |
| K974619 | Scanaray/Cd-Dent Advanced Computerized X-Ray SystemLMA · Traditional | 02/25/1998SE |
| K950288 | Autolaser Multi Format CameraLMC · Traditional | 04/04/1995SE |
| K930761 | Image-X 70 Intraoral X-Ray SystemEAP · Traditional | 05/25/1993SE |
| K925684 | Olymp-X,X-Ray GeneratorIZO · Traditional | 02/02/1993SE |
Questions and answers
When was Afp 17 X 4 Automatic Film Processor cleared by the FDA?
Afp 17 X 4 Automatic Film Processor (K925885) received a 510(k) decision of Substantially Equivalent on June 9, 1993, 205 days after the submission was received.
What is the product code of K925885?
The FDA product code is IXW – Processor, Radiographic-Film, Automatic, a Class II (moderate risk) device regulated under 21 CFR 892.1900.