3M XP-2000 X-Ray Film Processor
FDA 510(k) K940558 · 3M Company
510(k) numberK940558
Submission
- Device name
- 3M XP-2000 X-Ray Film Processor
- Applicant
- 3M Company
St. Paul, MN, US - Received
- February 7, 1994
- Decision date
- March 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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Questions and answers
When was 3M XP-2000 X-Ray Film Processor cleared by the FDA?
3M XP-2000 X-Ray Film Processor (K940558) received a 510(k) decision of Substantially Equivalent on March 22, 1994, 43 days after the submission was received.
What is the product code of K940558?
The FDA product code is IXW – Processor, Radiographic-Film, Automatic, a Class II (moderate risk) device regulated under 21 CFR 892.1900.