Nucamma Rx Modification

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

Full name

Modification to: Nucamma Rx

510(k) Number

K032779 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Nucamma BI90

  Class II

  FDA 510(k) K003882 Active Cleared 21 Feb 2001

• Mobile Single Circular Camera (Msc) & Mobile Digital Cardiac Camera (Mdcc)

  Class II

  FDA 510(k) K033956 Active Cleared 20 Jan 2004

• Nucamma R+

  Class II

  FDA 510(k) K982044 Active Cleared 2 Sep 1998

• Nucamma Rx

  Class II

  FDA 510(k) K982045 Active Cleared 2 Sep 1998

• Mobile Compact Digital Cardiac Camera

  Class II

  FDA 510(k) K040057 Active Cleared 2 Feb 2004

• Bcc Gamma Camera

  Class II

  FDA 510(k) K013667 Active Cleared 28 Jan 2002

• What is the primary purpose of the Nucamma Rx Modification in a clinical setting?

  The Nucamma Rx Modification is designed as a Computed Emission Tomography (CET) system to detect gamma ray- and positron-emitting radionuclides within the body. It reconstructs cross-sectional images through computer analysis, enabling precise localization and assessment of radiotracer distribution—critical for diagnostic imaging in radiology, particularly in nuclear medicine.

• How is the regulatory pathway for this device determined, and what does that mean for its use?

  The Nucamma Rx Modification received FDA 510(k) clearance under a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device. This classification places it as a Class II medical device (regulation 892.1200), requiring compliance with established safety and performance standards for nuclear medicine imaging. No third-party involvement is required for its use.

• Does this device come in multiple configurations or sizes, and if so, how are they identified?

  Yes, the device is associated with multiple registration numbers and FEI numbers (e.g., 3015232217, 3002808139, etc.), which likely correspond to different models or configurations. These identifiers are used in regulatory filings, but the exact specifications (e.g., detector sizes, field-of-view) are not provided in the data. Contacting the manufacturer, Is2 Research, Inc., would clarify available models for your specific application.

• Is the Nucamma Rx Modification intended for single-use or reusable applications?

  The provided data does not specify reuse or single-use details for the Nucamma Rx Modification. However, as a Computed Emission Tomography system, such devices are typically designed for repeated clinical use with appropriate maintenance protocols. Sterility is not mentioned, so it likely requires cleaning and calibration between patients, following manufacturer guidelines.

• What type of facility or department would typically use this device, and why?

  This device is explicitly intended for radiology settings, particularly those specializing in nuclear medicine imaging. Its purpose—detecting and reconstructing images of radiotracers—aligns with diagnostic workflows in hospitals, clinics, or research centers where precise localization of metabolic or functional processes (e.g., oncology, cardiology) is required. The advisory committee classification under *Radiology* further confirms its role in this domain.