ACQSIM-MULTISLICE-CT, MODEL 453567042271

K033357 · Philips Medical Systems (Cleveland), Inc. · JAK · Jan 9, 2004 · Radiology

Device Facts

• Record ID: K033357
• Device Name: ACQSIM-MULTISLICE-CT, MODEL 453567042271
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: JAK · Radiology
• Decision Date: Jan 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The "AcQSim-Multislice-CT" is a Whole Body Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Device Story

AcQSim-Multislice-CT is a whole-body CT scanner featuring a continuously rotating gantry with X-ray tube and detectors; supports multi-slice acquisition (up to 40 slices simultaneously). Device acquires X-ray transmission data at various angles/planes; computer reconstructs data into cross-sectional body images. System includes signal analysis, display equipment, and patient supports. Used in clinical settings by trained medical professionals. Output consists of reconstructed images for diagnostic visualization. Healthcare providers use images to inform clinical decision-making and patient diagnosis. Benefits include high-resolution anatomical imaging for diagnostic assessment.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via bench testing, adherence to GMP, and compliance with international standards (IEC 60601-1) and federal radiation performance standards (21 CFR Subchapter J).

Technological Characteristics

Whole-body CT scanner; multi-slice capability (up to 40 slices); continuously rotating gantry; X-ray transmission sensing. Electrical/mechanical safety per IEC 60601-1. Radiation safety per 21 CFR Subchapter J. Software-based image reconstruction.

Indications for Use

Indicated for whole body computed tomography imaging in patients requiring diagnostic x-ray transmission data reconstruction. Prescription use only.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• AcQSim-CT (K001088)
• Mx8000 IDT (K012009)
• Mx8000 v5.0 (K010817)

Submission Summary (Full Text)

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# Philips Medical Systems (Cleveland), Inc. 510(k) Summary

Ko 3357

## "AcQSim-Multislice-CT" CT Scanner

#### 1. Submitter

Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 [phone]

#### Contact:

Robert B. Smith Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 Telephone: [phone] FAX: [phone]

Date of Summary: October 17, 2003

#### 2. Device Name and Classification

"AcQSim-Multislice-C1" CT Scanner Device Name:

Classification Name: Computed Tomography X-Ray System

The FDA has classified the Computed Tomography X-Ray System as Class II in 21 CFR 892.1750 (Product Code 90JAK)

#### 3. Device Description

The "AcQSim-Multislice-CT" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 40 slices simultancously. The acquired x-ray transmission data is reconstructed by computer into images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and cquipment supports, components and accessories.

#### 4. Intended Use Of The Device

The "AcQSim-Multislicc-CT" is a Whole Body Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

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### 5. Comparison to Predicate Devices

In the opinion of Philips Medical Systems (Cleveland), Inc., the

"AcQSim-Multislice-CT" CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely:

- AcQSim-CT, K001088 .
- Mx8000 IDT, K012009 .
- Mx8000 v5.0, K010817 .

# 6. Safety and Effectiveness Considerations

The safety of the device is assured by adherence to GMP practices and to International Standards. Potential hazards are identified in a hazard analysis and controlled in the following manner:

Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.

Electrical and Mcchanical safety is assured by adherence to IEC 60601-1 standards. Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards.

## 7. Substantial Equivalency Statement

Based on the above considerations, it is Philips's opinion that the "AcQSim-Multislice-CT" CT scanner is substantially cquivalent in safety and effectiveness to the predicate devices, AcQSim-CT, K001088, Mx8000 IDT, K012009 and Mx8000 v5.0, K010817.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

JAN - 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert B. Smith Quality System Manager Philips Medical Systems (Cleveland), Inc. 595 Miner Rd. HIGHLAND HEIGHTS OH 44143

Re: K033357 Trade/Device Name: AcQSim-Multislice-CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 17, 2003 Received: October 22, 2003

Dear Mr. Smith:

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 to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. bugden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO33357 510(k) Number (if known):

Page 1 of 1

"AcQSim-Multislice-CT" Device Name:

The "AcQSim-Multislice-CT" is a Computed Indications for Use: Tomography X-Ray System intended to produce images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033357 5

Over-The-Counter Use

(Optional Format 1-2-96)