DRYSTAR AXYS, MODEL EYZ4E
FDA 510(k) clearance K072680 · decided 2007-10-25
Clearance details
- K-number
- K072680
- Device name
- DRYSTAR AXYS, MODEL EYZ4E
- Applicant
- Agfa Healthcare Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-09-24
- Decision date
- 2007-10-25
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- LMC
- Device class
- 2
- Regulation number
- 892.2040
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Greenville, SC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Agfa Healthcare Corporation
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventiona recall (Z-2136-2008) | AGFA Corp. | 2008-09-18 |