510(k) K981280
- Device
- CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
- Applicant
- BAYER CORP., AGFA DIV.
- 510(k) number
- K981280
- Product code
- IXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-30
- Date received
- 1998-04-08
- Regulation
- 892.1900
- Classification name
- Processor, Radiographic-film, Automatic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL SULLIVAN
- Address
- 100 Challenger Rd. Ridgefield Park NJ US 07660 07660
FDA Registration Numbers#
- 3014150341
- 3003982003
Source Documents#
Other 510(k) Records For Product Code IXW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111167 | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT | Velopex International, Inc. | 2011-08-18 |
| K093503 | INTRAX FILM PROCESSOR | Velopex International, Inc. | 2010-01-06 |
| K091628 | OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX | Protec GmbH & Co. KG | 2009-08-21 |
| K024342 | RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 | Daito Co., Ltd. | 2003-04-23 |
| K023801 | FILM PROCESSOR, MODEL LIFE RAY PRO 1000 | S.A.I.E.P. S.R.L. | 2003-02-12 |
| K023825 | FILM PROCESSOR, MODEL LIFE RAY PRO 2500 | S.A.I.E.P. S.R.L. | 2003-02-12 |
| K023613 | AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 | Alphatek Corp. | 2003-01-23 |
| K022154 | LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D | Fischer Industries, Inc. | 2002-09-30 |
| K002640 | FREEDOM AUTOMATIC FILM PROCESSOR | J. Morita USA, Inc. | 2000-11-08 |
| K002404 | MICRO-MAX, MODEL 319 | Tek Marketing, Inc. | 2000-08-30 |
| K001321 | ALL-PRO 2010 | All-Pro Imaging Corp. | 2000-05-16 |
| K992818 | OPTIMAX/ COMPACT 2 | Protec GmbH & Co. KG | 1999-09-01 |
| K990969 | KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR | Konica Medical Corp. | 1999-06-18 |
| K991435 | AII-PRO 100 PLUS AND ALL-PRO 200 | All-Pro Imaging Corp. | 1999-05-20 |
| K973125 | MAMMOLOADER BY C.M.A. SRL | C.M.A. | 1997-10-08 |
Legacy Summary#
summary
FDA Review#
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