KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345— 510(k) K051258
Substantially EquivalentEastman Kodak Company
FDA 510(k) clearance K051258 for KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345, Substantially Equivalent on 2005-06-01. Applicant: Eastman Kodak Company. Device class: 2.
Clearance details
- Applicant
- Eastman Kodak Company
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rochester, NY, US
Recent devices under product code KPR
view allMore clearances from Eastman Kodak Company
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K051258
K-number listed on FDA's recall record- Z-2177-2014 — Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
- Z-0844-2014 — KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
- Z-0798-2014 — DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051258.
Data sourced from openFDA. This site is unofficial and independent of the FDA.