ANYSCAN-S SPECT IMAGING SYSTEM

K131625 · Absolute Imaging Solutions · KPS · Oct 3, 2013 · Radiology

Device Facts

• Record ID: K131625
• Device Name: ANYSCAN-S SPECT IMAGING SYSTEM
• Applicant: Absolute Imaging Solutions
• Product Code: KPS · Radiology
• Decision Date: Oct 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.

Device Story

AnyScan-S is a single- or dual-detector gamma camera system designed for nuclear medicine imaging. It captures radiation emissions from radionuclides administered to patients to produce planar, whole-body, and tomographic (SPECT) images. The system is intended for use in clinical settings to assist healthcare providers in visualizing physiological distribution of radiopharmaceuticals. By providing high-throughput imaging capabilities, it supports diagnostic assessment of organ function and pathology. Clinicians interpret the resulting images to inform clinical decision-making and patient management. The device operates by detecting gamma rays, transforming these inputs into diagnostic images, and displaying them for physician review.

Clinical Evidence

Clinical images were obtained from human subjects. Tomographic image quality was found to be at least equal to images produced by reference predicate devices. Bench testing was conducted using NEMA NU1 phantoms under standard protocols, confirming performance met or exceeded predicate specifications. Electrical safety testing was also performed and met applicable standards.

Technological Characteristics

Single- or dual-detector gamma camera system. Supports planar, static, dynamic, SPECT, and whole-body imaging. Performance validated against NEMA NU1 phantom standards. Electrical safety testing conducted per applicable standards.

Indications for Use

Indicated for detection or imaging of radionuclide distribution in the body or organs via planar, whole body, and tomographic imaging techniques.

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.

Predicate Devices

• Symbia-E - Siemens (K072567)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo with the letters 'ais' in a stylized font. Above the letters, there is a graphic that resembles a burst or a cluster of dots, possibly representing energy or innovation. The letters 'ais' are bold and appear to be the focal point of the logo. Below the letters, there is some smaller text that is difficult to read due to the image quality.

Absolute Imaging Solutions 8205 Boo G Court. Stokesdate. NC 27357 . Phone: [phone]

AnyScan-S 5 10(k) Premarket Notification

K131625

# SECTION G 510(K) SUMMARY

In accordance with 21CFR 807.92

#### Submitter Information 1.0

Absolute Imaging Solutions Name:

8205 B&G Court Address: Stokesdale, NC 27357 USA

336-643-2000 Phone: [phone] Fax:

ОСТ 0 3 2013

Contact Person: Mark Shina, President

Date of Submission: 22 May 2013

#### Device Identification 2.0

AnyScan-S SPECT Imaging System Name of Device: Gamma Camera – SPECT Imaging System Common Name: Classification Name: Emission Computed Tomography System (ECT)

#### Predicate Devices 3.0

1. Symbia-E - Siemens [K072567]

#### Intended Use / Indications for Use 4.0

For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.

{1}------------------------------------------------

Absolute Imuging Solutions 8205 BerG Court. Stokesdale, NC 27357 . Phone: [phone]

Image /page/1/Picture/2 description: The image shows a logo with the letters 'ais' in a stylized font. Above the letters, there is a circular design with dots around it, resembling a stylized eye or a technological symbol. Below the letters, there is a smaller line of text that reads 'accurate imaging solutions'.

### Technological Characteristics 5.0

The AnyScan-S is a Single- or Dual-Detector Gamma Camera System that rne Anyolanar static, dynamic as well as SPECT and whole body imaging applications with high patient throughput requirements.

As such, the AnyScan-S SPECT Imaging System raises no new issues of safety or efficacy.

#### Performance Testing and Data 6.0

Performance testing was performed using NEMA NUI phantoms, under the NEMA Standard test protocols. In all cases, performance of the AnyScan-S device met or exceeded that of predicate devices.

Clinical images were obtained using the AnyScan-S in human subjects. Tomographic image quality was at least equal to images produced by reference predicate devices.

Furthermore, electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria.

#### Substantial Equivalence 7.0

The AnyScan-S SPECT Imaging System has the same intended use, similar principles of operation, and consistent technological characteristics as the predicate devices. Thus, the AnyScan-S is substantially equivalent to the predicate devices and no new safety or effectiveness concerns are raised.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is facing to the right.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WObti-GoDS Silver Spring, MD 20993-0002

October 3. 2013

Absolute Imaging Solutions % Mr. Mark Shina President 8205 B&G Court STOKESDALE NC 27357

Re: K131625

Trade/Device Name: AnyScan-S SPECT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: September 18, 2013 Received: September 27, 2013

Dear Mr. Shina:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

## Page 2 - Mr. Mark Shina

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.ida.gov/MedicalDevices/Safety/ReportalProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris Director, Division Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): k131625

Device Name: AnyScan-S

Indications for Use:

For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) k131625

AND/OR

Page I of I