MAMMO-300 Automatic X-Ray Film Processor
FDA 510(k) K931882 · Alphatek Corp.
510(k) numberK931882
Submission
- Device name
- MAMMO-300 Automatic X-Ray Film Processor
- Applicant
- Alphatek Corp.
Chicago, IL, US - Received
- April 14, 1993
- Decision date
- August 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K023613 | AX200 Automatic X-Ray Film Processor, Model 6586.036IXW · Traditional | 01/23/2003SE |
| K931883 | AX-390SE Automatic X-Ray Film Processor 9586.033IXW · Traditional | 08/23/1993SE |
| K925569 | AX-700LE Automatic X-Ray Film ProcessorIXW · Traditional | 01/15/1993SE |
| K924430 | AX-300SE Automatic X-Ray Film Processor, 6586.027IXW · Traditional | 11/27/1992SE |
Questions and answers
When was MAMMO-300 Automatic X-Ray Film Processor cleared by the FDA?
MAMMO-300 Automatic X-Ray Film Processor (K931882) received a 510(k) decision of Substantially Equivalent on August 23, 1993, 131 days after the submission was received.
What is the product code of K931882?
The FDA product code is IXW – Processor, Radiographic-Film, Automatic, a Class II (moderate risk) device regulated under 21 CFR 892.1900.