CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
FDA 510(k) clearance K981280 · decided 1998-04-30
Clearance details
- K-number
- K981280
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-08
- Decision date
- 1998-04-30
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- IXW
- Device class
- 2
- Regulation number
- 892.1900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ridgefield Park, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bayer Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| FREEDOM AUTOMATIC FILM PROCESSOR (K002640) | J. Morita USA, Inc. | 2000-11-08 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.