Who is the manufacturer of POSITRON COINCIDENCE DETECTION?

Philips Medical Systems (Cleveland), Inc. filed the 510(k) submission for POSITRON COINCIDENCE DETECTION (K960192).

What is the FDA product code for POSITRON COINCIDENCE DETECTION?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for POSITRON COINCIDENCE DETECTION?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like POSITRON COINCIDENCE DETECTION?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

POSITRON COINCIDENCE DETECTION

K960192 · Philips Medical Systems (Cleveland), Inc. · KPS · Sep 12, 1996 · Radiology

Device Facts

Record ID	K960192
Device Name	POSITRON COINCIDENCE DETECTION
Applicant	Philips Medical Systems (Cleveland), Inc.
Product Code	KPS · Radiology
Decision Date	Sep 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2

Intended Use

The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions.

Device Story

PCD Option adds hardware/software to Prism Dual Head gamma camera system; enables positron coincidence detection (PCD) imaging. Operated by trained healthcare professionals in clinical nuclear medicine settings. Device transforms gamma/coincidence signals into diagnostic images of organs and lesions. Output viewed by physicians to assess anatomy/pathology; aids clinical decision-making regarding organ function and lesion identification. Benefits include improved image quality and sensitivity over standard gamma cameras.

Clinical Evidence

Bench testing only. Laboratory tests demonstrated improved image quality and sensitivity compared to standard gamma camera. No clinical data provided.

Technological Characteristics

Gamma camera system with positron coincidence detection (PCD) hardware and software. Electrical safety certified to IEC-601. System performs diagnostic imaging of organs and lesions.

Indications for Use

Indicated for diagnostic imaging of organs and lesions in patients undergoing Nuclear Medicine diagnostic examinations.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Related Devices

K970627 — E. CAM COINCIDENCE MODE (CM) · Siemens Medical Solutions USA, Inc. · Sep 4, 1997
K964712 — PRISM XPVT SYSTEM (210823) · Philips Medical Systems (Cleveland), Inc. · Feb 21, 1997
K972686 — VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER · Smv America · Oct 14, 1997
K214062 — Radialis PET Camera · Radialis, Inc. · Feb 4, 2022
K963273 — VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION · Smv America · Mar 11, 1997

Submission Summary (Full Text)

{0} SEP 12 1990 K 960/92 PICKER INTERNATIONAL 510(k) NOTICE # PCD OPTION TO THE PRISM DUAL HEAD SYSTEM E: SUMMARY OF SAFETY AND EFFECTIVENESS (Revised) This is a summary of the information submitted by Picker International, Inc. To the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Positron Coincidence Option (PCD). The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system. Functional specifications and operator’s instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units. The PCD option to the Prism Dual Head system is substantially equivalent to legally marketed devices. The PCD option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The PCD option will be certified to electrical safety standards (IEC-601) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator’s Manual) will be provided to the user of the equipment. Laboratory tests have shown that the PCD option has improved image quality and sensitivity compared to a standard gamma camera. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the PCD option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device. Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the PCD option. In addition, all information contained in this 510(k) Notice is accurate and complete.