IXW · Processor, Radiographic-Film, Automatic
Radiology · 21 CFR 892.1900 · Class 2
Overview
| Product Code | IXW |
|---|---|
| Device Name | Processor, Radiographic-Film, Automatic |
| Regulation | 21 CFR 892.1900 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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 | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT | Velopex International, Inc. | Aug 18, 2011 | SESE |
| K093503 | INTRAX FILM PROCESSOR | Velopex International, Inc. | Jan 6, 2010 | SESE |
| K091628 | OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX | Protec GmbH & Co. KG | Aug 21, 2009 | SESE |
| K024342 | RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 | Daito Co., Ltd. | Apr 23, 2003 | SESE |
| K023825 | FILM PROCESSOR, MODEL LIFE RAY PRO 2500 | S.A.I.E.P. S.R.L. | Feb 12, 2003 | SESE |
| K023801 | FILM PROCESSOR, MODEL LIFE RAY PRO 1000 | S.A.I.E.P. S.R.L. | Feb 12, 2003 | SESE |
| K023613 | AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 | Alphatek Corp. | Jan 23, 2003 | SESE |
| K022154 | LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D | Fischer Industries, Inc. | Sep 30, 2002 | SESE |
| K002640 | FREEDOM AUTOMATIC FILM PROCESSOR | J. Morita USA, Inc. | Nov 8, 2000 | SESE |
| K002404 | MICRO-MAX, MODEL 319 | Tek Marketing, Inc. | Aug 30, 2000 | SESE |
| K001321 | ALL-PRO 2010 | All-Pro Imaging Corp. | May 16, 2000 | SESE |
| K992818 | OPTIMAX/ COMPACT 2 | Protec GmbH & Co. KG | Sep 1, 1999 | SESE |
| K990969 | KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR | Konica Medical Corp. | Jun 18, 1999 | SESE |
| K991435 | AII-PRO 100 PLUS AND ALL-PRO 200 | All-Pro Imaging Corp. | May 20, 1999 | SESE |
| 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. | Apr 30, 1998 | SESE |
| K973125 | MAMMOLOADER BY C.M.A. SRL | C.M.A. | Oct 8, 1997 | SESE |
| K970059 | KODAK MINILOADER(2000) | Eastman Kodak Company | Jan 27, 1997 | SESE |
| K962750 | 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR | Imation Corp. | Aug 21, 1996 | SESE |
| K955706 | JPI AUTOMATIC X-RAY FILM PROCESSOR | Jpi Healthcare Co, Ltd. | Feb 12, 1996 | SESE |
| K951373 | 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
