Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1900](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1900) → IXW — Processor, Radiographic-Film, Automatic # IXW · Processor, Radiographic-Film, Automatic _Radiology · 21 CFR 892.1900 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW ## Overview - **Product Code:** IXW - **Device Name:** Processor, Radiographic-Film, Automatic - **Regulation:** [21 CFR 892.1900](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1900) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## Identification An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. ## Recent Cleared Devices (20 of 83) Showing 20 most recent of 83 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K111167](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K111167.md) | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT | Velopex International, Inc. | Aug 18, 2011 | SESE | | [K093503](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K093503.md) | INTRAX FILM PROCESSOR | Velopex International, Inc. | Jan 6, 2010 | SESE | | [K091628](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K091628.md) | OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX | Protec GmbH & Co. KG | Aug 21, 2009 | SESE | | [K024342](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K024342.md) | RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 | Daito Co., Ltd. | Apr 23, 2003 | SESE | | [K023825](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K023825.md) | FILM PROCESSOR, MODEL LIFE RAY PRO 2500 | S.A.I.E.P. S.R.L. | Feb 12, 2003 | SESE | | [K023801](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K023801.md) | FILM PROCESSOR, MODEL LIFE RAY PRO 1000 | S.A.I.E.P. S.R.L. | Feb 12, 2003 | SESE | | [K023613](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K023613.md) | AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 | Alphatek Corp. | Jan 23, 2003 | SESE | | [K022154](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K022154.md) | LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D | Fischer Industries, Inc. | Sep 30, 2002 | SESE | | [K002640](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K002640.md) | FREEDOM AUTOMATIC FILM PROCESSOR | J. Morita USA, Inc. | Nov 8, 2000 | SESE | | [K002404](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K002404.md) | MICRO-MAX, MODEL 319 | Tek Marketing, Inc. | Aug 30, 2000 | SESE | | [K001321](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K001321.md) | ALL-PRO 2010 | All-Pro Imaging Corp. | May 16, 2000 | SESE | | [K992818](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K992818.md) | OPTIMAX/ COMPACT 2 | Protec GmbH & Co. KG | Sep 1, 1999 | SESE | | [K990969](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K990969.md) | KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR | Konica Medical Corp. | Jun 18, 1999 | SESE | | [K991435](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K991435.md) | AII-PRO 100 PLUS AND ALL-PRO 200 | All-Pro Imaging Corp. | May 20, 1999 | SESE | | [K981280](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K981280.md) | 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. | Apr 30, 1998 | SESE | | [K973125](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K973125.md) | MAMMOLOADER BY C.M.A. SRL | C.M.A. | Oct 8, 1997 | SESE | | [K970059](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K970059.md) | KODAK MINILOADER(2000) | Eastman Kodak Company | Jan 27, 1997 | SESE | | [K962750](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K962750.md) | 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR | Imation Corp. | Aug 21, 1996 | SESE | | [K955706](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K955706.md) | JPI AUTOMATIC X-RAY FILM PROCESSOR | Jpi Healthcare Co, Ltd. | Feb 12, 1996 | SESE | | [K951373](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW/K951373.md) | FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ | Fujifilm Medical System U.S.A., Inc. | Oct 27, 1995 | SESE | ## Top Applicants - Eastman Kodak Company — 31 clearances - Konica Medical Corp. — 7 clearances - Alphatek Corp. — 5 clearances - Fujifilm Medical System U.S.A., Inc. — 4 clearances - 3M Company — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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