FREEDOM AUTOMATIC FILM PROCESSOR
FDA 510(k) clearance K002640 · decided 2000-11-08
Clearance details
- K-number
- K002640
- Device name
- FREEDOM AUTOMATIC FILM PROCESSOR
- Applicant
- J. Morita USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-24
- Decision date
- 2000-11-08
- Days to decision
- 76 days
- Clearance type
- Abbreviated
- Product code
- IXW
- Device class
- 2
- Regulation number
- 892.1900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (K111167) | Velopex International, Inc. | 2011-08-18 |
| INTRAX FILM PROCESSOR (K093503) | Velopex International, Inc. | 2010-01-06 |
| OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX (K091628) | Protec GmbH & Co. KG | 2009-08-21 |
| RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 (K024342) | Daito Co., Ltd. | 2003-04-23 |
| FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (K023825) | S.A.I.E.P. S.R.L. | 2003-02-12 |
| FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (K023801) | S.A.I.E.P. S.R.L. | 2003-02-12 |
| AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (K023613) | Alphatek Corp. | 2003-01-23 |
| LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (K022154) | Fischer Industries, Inc. | 2002-09-30 |
| MICRO-MAX, MODEL 319 (K002404) | Tek Marketing, Inc. | 2000-08-30 |
| ALL-PRO 2010 (K001321) | All-Pro Imaging Corp. | 2000-05-16 |
| OPTIMAX/ COMPACT 2 (K992818) | Protec GmbH & Co. KG | 1999-09-01 |
| KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR (K990969) | Konica Medical Corp. | 1999-06-18 |
Recalls involving this device
No recalls on record reference this clearance.