Oldelft Digidelca

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K980296 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Therapax HT 150T

  Class II

  FDA 510(k) K861431 Active Cleared 21 May 1986

• Simulix-Hp

  Class II

  FDA 510(k) K946128 Active Cleared 12 May 1995

• N 800 Hf

  Class I

  FDA 510(k) K950037 Active Cleared 15 Feb 1995

• Electrodelca

  Class II

  FDA 510(k) K892659 Active Cleared 21 Nov 1989

• Amber Du

  Class II

  FDA 510(k) K973219 Active Cleared 8 Oct 1997

• Papillion Proctoscope

  Class II

  FDA 510(k) K914784 Active Cleared 5 Jun 1992

See all devices from Old Delft Corp. of America →

• What is the Oldelft Digidelca used for?

  The Oldelft Digidelca is a stationary X-ray system designed specifically for radiography applications. It produces high-quality digital radiographic images, enabling detailed visualization of internal body structures for medical evaluation. This makes it ideal for clinical environments where fixed-position imaging is required, such as hospitals or diagnostic centers.

• Is the Oldelft Digidelca a single-use or reusable device?

  The Oldelft Digidelca is neither classified as a single-use nor a reusable device in a sterile context. It is supplied as a stationary unit with non-sterile components, intended for repeated use in clinical settings where fixed-position radiography is necessary. Its design ensures durability for ongoing diagnostic imaging tasks.

• What regulatory approval does the Oldelft Digidelca hold?

  The Oldelft Digidelca holds FDA clearance under a 510(k) submission (K980296). This classification confirms it is deemed substantially equivalent to a legally marketed predicate device and falls under the regulatory category of KPR (Radiology). The device was reviewed by the Radiology Advisory Committee (RA) and cleared for use in stationary X-ray imaging applications.

• How is the Oldelft Digidelca supplied, and what are its key features?

  The Oldelft Digidelca is supplied as a complete stationary X-ray system, designed for fixed-position use in clinical radiology settings. It integrates digital imaging technology to capture high-resolution radiographic images, ensuring clarity and precision for diagnostic purposes. The system is non-sterile and intended for long-term use in environments requiring reliable, high-quality imaging.

• Are there any specific storage or handling requirements for the Oldelft Digidelca?

  While the provided data does not specify detailed storage instructions, stationary X-ray systems like the Oldelft Digidelca generally require a stable, controlled environment to protect against physical damage, electrical interference, or environmental factors. Ensure the unit is placed on a level, non-conductive surface away from direct sunlight or moisture. Follow manufacturer guidelines for maintenance and calibration to sustain optimal performance.