SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600

K052447 · Analogic Corp. · JAK · Sep 21, 2005 · Radiology

Device Facts

• Record ID: K052447
• Device Name: SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
• Applicant: Analogic Corp.
• Product Code: JAK · Radiology
• Decision Date: Sep 21, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Device Story

Multislice CT scanner system consisting of gantry, patient table, and operator console. Inputs: X-ray transmission data acquired at various angles/planes. Operation: 16-row detector; 0.50s minimum scan time; high-speed reconstruction engine. Outputs: Reconstructed head and whole-body images displayed on high-resolution monitors. Used in clinical settings by trained operators. Supports spiral, axial, dynamic, scout, CT fluoro, and ECG-gated acquisition modes. Includes 3D software, local archiving, and DICOM-based interconnectivity. Provides weighted CTDI, Dose Length Product, and geometric efficiency metrics to assist clinicians in monitoring radiation dose and image quality. Benefits include diagnostic imaging of head and body structures.

Clinical Evidence

Bench testing only. Performance validated against requirements specifications and radiological safety standards (21CFR Subchapter J). Image quality performance (high-contrast spatial resolution, low-contrast resolution) compared to predicates using phantoms.

Technological Characteristics

16-slice CT scanner; 70cm gantry aperture; 16-row detector. Power: 60kW or 72kW PSU. Connectivity: DICOM-based. Standards: IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-2-32, 60601-2-44. Software: 3D reconstruction engine.

Indications for Use

Indicated for head and whole-body imaging via computer reconstruction of X-ray transmission data. No specific patient population, age, or contraindications provided.

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

• GE Lightspeed 6.0 CT Scanner System (K033502)
• GE Lightspeed 5.0 CT Scanner System (K030420)
• Toshiba Aquilion 16 CFX (K020385, K022050)

Submission Summary (Full Text)

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

# Kos 2447

# SEP 2 1 2005

# 510(k) SUMMARY

## FOR

## Analogic Corporation

## SyneRad IMPACT 60, SyneRad IMpact 72 and Analogic AMS1600 Submitter's Name and Address

| Submitter's Name: | Analogic Corporation | | |
|-----------------------|----------------------|--|--|
| Address: | 8 Centennial Drive | | |
| City, State, and Zip: | Peabody, MA, 01960 | | |

#### Contact Person

| Name: | Donald J Sherratt |
|------------|---------------------------------|
| Title: | Director of Regulatory Affairs |
| Telephone: | ( 978 ) 977-3000 extension 4075 |
| Facsimile: | ( 978 ) 977-6808 |
| E-mail: | [e-mail] |

#### Manufacturing Facility Address

| Manufacturer: | Analogic Corporation |
|-----------------------|----------------------|
| Address: | 8 Centennial Drive |
| City, State, and ZIP: | Peabody, MA, 01960 |

## Establishment Registration Number

Est. Registration Number: 1220672

#### New Device Details

#### Proprietary of Trade Names

| Proprietary or Trade<br>Name: | SyneRad IMPACT 60<br>SyneRad Impact 72 and<br>Analogic AMS1600 |
|-------------------------------|----------------------------------------------------------------|
|-------------------------------|----------------------------------------------------------------|

#### New Device Common Name

Common Name:

Computed Tomography X-ray system

#### New Device Class

Device Class:

Class II

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

#### New Device Product Code

Device Procode:

| New Device CFR | |
|---------------------------------|-------------------------------------|
| Device CFR: | 892.1750 |
| New Device Classification Panel | |
| Classification Panel: | Radiology |
| New Device Classification Name | |
| Classification Name: | System, X-ray, Tomography, Computed |
| Reason for submission | |
| Reason for submission | New Devices |
| Comparison with predicates | |
| Predicate #1<br>K033502 | GE Lightspeed 6.0 CT Scanner System |
| Predicate #2<br>K030420 | GE Lightspeed 5.0 CT Scanner System |

90JAK

#### Description of These Devices

The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems consist of a gantry, a patient table and an operator console.

Predicate #3 K020385, K022050 Toshiba Aquilion 16 CFX

All three CT Systems are virtually identical. The physical size of all three systems is the same and they use the same control console, operating system and software. The Analogic AMS1600 is the platform from which the two Anexa systems are built and is identical in construction (except for cosmetics created by the covers) to the SyneRad IMpact 72. The difference between the SyneRad IMPACT 60 and the SyneRad IMpact 72 is the output rating of the High Voltage Power Supply mounted on the gantry. The SyneRad IMPACT 60 has a 60 kW PSU whereas the SyneRad IMpact 72 has a 72 kW PSU. The kVp levels are the same for both systems. The upper mA setting for the 60 kW system is 500 mA. The upper mA setting for the 72 kW system is 600 mA. The High Voltage Power Supply provides feedback to the control computer which selects the upper mA limit.

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

These 16-slice CT scanners have a gantry aperture opening of 70 centimeters. They are based on proven Analogic computed tomography technology. They have a 16-row detector and a 0.50 second minimum scan time. High-speed image reconstruction is from an innovative reconstruction engine. The operator console is supplied with two 20-inch high resolution monitors. 3D software is standard. Workflow and patient throughput requirements are supported by local archiving and DICOM-based interconnectivity features.

#### Summary of Intended Uses

The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS 1600 are Computed Tomography X-ray Systems intended to produce images of the head and whole body by computer reconstruction of X-ray transmission data at different angle and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

#### Comparison of Technological Characteristics

The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems utilize the same technological characteristics and operating principles, are comparable in key safety and effectiveness and QA features, and uses the same basic design, construction and materials.

They also have the same intended use and modes of operation (CT scanning throughout the whole body including Spiral, Axial, Dynamic, Scout modes, additional optional scan modes like CT fluoro and ECG gated acquisition). Their X-ray power and technique factors are comparable to the predicate devices. They also have comparable image quality performance (measured on phantoms) as the predicate devices. The control console displays weighted CTDI, Dose Length Product and geometric efficiency in a method similar to the predicate devices.

In the opinion of Analogic Corporation, the SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 are of comparable type and substantially equivalent to the currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have the same intended use. These new devices will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33 as well as the safety requirements of UL 60601-1 and IEC 60601-1 and associated collateral and particular standards.

| | Anexa | | G. E. Healthcare | | Toshiba |
|------------------------------------------------------|-----------------------------|-----------------------------|--------------------------------------|-----------------------------------|-----------------------------------|
| Model | IMPACT72 | IMPACT 60 | LightSpeed 6.0<br>(LightSpeed Pro16) | LightSpeed 5.0<br>(LightSpeed 16) | AQUILION 16 CFX |
| K Number | New Devices | | K033502 | K030420 | K020385 and K022050 |
| Spiral, Axiel, Dynamic and Scout Scanning | Yes | | Yes | Yes | Yes |
| CT fluoro end ECG gated scan mode | Optional | | Optional | Optional | Optional |
| kW output | 72 kW | 60 kW | 100 kW | 53.2 kW | 60 kW |
| kVp Range | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 140 kVp | 80, 100, 120, 135 kVp |
| mA Range | 10 - 600 mA | 10 - 500 mA | 10 - 800 mA | 10 - 440 mA | 10 - 500 mA |
| High Contrast Spatial Res. | | | | | |
| 0% MTF, lp/cm | 17.25 lp/cm | 17.25 lp/cm | 15.4 lp/cm | 15.4 lp/cm | 18 lp/cm |
| 50% MTF, lp/cm | 8+ lp/cm | 8+ lp/cm | 8.5 lp/cm | 8.5 lp/cm | 9.4 lp/cm |
| Low-contrast res., mm @ % @ 4 rads | 5 mm @ 0.30%,<br>8" CATPHAN | 5 mm @ 0.30%,<br>8" CATPHAN | 5 mm @ 0.30%,<br>8" CATPHAN | 5 mm @ 0.30%,<br>8" CATPHAN | 5 mm @ 0.3% @ 21.8 mGy (per MHRA) |
| Weighted CTDI shown on console | Yes | | Yes | Yes | Yes |
| Dose Length Product shown on console | Yes | | Yes | Yes | Yes |
| Geometric Efficiency displayed on console when < 70% | Yes | | Yes | Yes | Yes |

#### Key Parameters Comparison Chart

September 1, 2005 APPENDIX E Analogic Corporation SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600CT Systems 510(k) Page 3 of 4

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

#### Compliance with Voluntary Standards

Before final market release, the SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 Multislice Computed Tomography Systems will be thoroughly validated at the unit and system level to meet all elements of its Requirements Specification. This includes the following non-clinical tests:

| Standards<br>No. | Standards<br>Organization | Standards Title | Version | Date |
|------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------|
| 60601-1-1 | IEC | Medical electrical equipment - Part 1-1:<br>General requirements for safety -<br>Collateral standard: Safety<br>requirements for medical electrical<br>systems | 2 | 2000 |
| 60601-1 | IEC | Medical Electrical Equipment- Part 1:<br>General Requirements for Safety | 2 +A1, +A2 | 1988, 1991, 1995 |
| 60601-1 | UL | Medical Electrical Equipment- Part 1:<br>General Requirements for Safety | 1 | 2003 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2:<br>General requirements for safety -<br>Collateral standard: Electromagnetic<br>compatibility - Requirements and tests | 2 | 2001 |
| 60601-1-3 | IEC | Medical electrical equipment - Part 1:<br>General requirements for safety - 3.<br>Collateral standard: General<br>requirements for radiation protection in<br>diagnostic X-ray equipment | 1 | 1994 |
| 60601-2-32 | IEC | Medical electrical equipment - Part 2:<br>Particular requirements for the safety of<br>associated equipment of X-ray<br>equipment | 1 | 1994 |
| 60601-2-44 | IEC | Medical electrical equipment - Part 2-<br>44: Particular requirements for the<br>safety of X-ray equipment for computed<br>tomography | 2.1 | 2002 |

#### Conclusion

Based on similarity in technology, characteristics and the same intended use as the predicates, and compliance with the Radiological Safety Regulations supported by bench testing, Analogic Corporation considers the SyneRad IMPACT 60, SyneRad IMPACT 72 and the Analogic AMS1600 substantially equivalent.

Bench testing demonstrates that the SyneRad IMPACT 60, SyneRad IMPACT 72 and the Analogic AMS1600 comply with 21CFR Subchapter J.

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

Image /page/4/Picture/2 description: The image shows a logo with a stylized bird figure. The bird is depicted with three curved lines representing its body and wings. The logo is surrounded by text arranged in a circular pattern, with the words following the curve of the circle. The text is in a simple, sans-serif font.

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Analogic Corporation c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K052447

K052447
Trade/Device Name: SyneRad Impact 60 and 72, and Analogic AMS1600
Trade/Device Name: 1200 and 720 Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 6, 2005 Received: September 7, 2005

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your Section 310(x) preniance institution indications for use stated in
above and have determined the device is substant in interstate commerce prior to above and have determined the devices is stessurites marketed in interstate commerce prior to
the enclosure) to legally marketed predicated in interses or to devices that hav the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the enactment aske of the Nical Dough and Cosmetic Act (Act) that the reclassified in accordance with the provisions of any a 125 a 125 and the election, market the do not require approval of a premance applivar a phical controls provisions of the Act
device, subject to the general controls provisions of the Act. The energing practice, f device, subject to the general controls provisions of die rear of
include requirements for annual registration, listing of devices, good manufacturing practice, labeling, mclude requirements.
and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into clice in (ciccial major regulations affecting your
Approval), it may be subject to such additions leises "Tele 21 Parts 800 to 8 Approval), it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations of the Rederel Register device can be found in the Code of I cacial regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issuance of a substances crequirements of the Act or any
FDA has made a determination that your device complex with answering with all FDA has made a determination that your developed with of the Packs. You must comply with all the Federal statutes and regulations administered of cessistation (21 CFR Part 807); labeling.
Act's requirements, including, but not limited to registration as set forth a the q Act's requirements, including, but not minuted to reguletents as torth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set fortugul (21 CFR Part 801); good manufacturity practice the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product rad (Sections 531-542 of the Act): 21 CFR 1000-1050.

{5}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the more The RD to fine of substantial courvalence of your device t This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalevice and t rine seen and the month of substantial equivalence of your device of your device to any good your device to proceed to the market.

If you desire specific advice on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (1) in 1977 in 1977 in 1977 at
contact the Office of Compliance at one of the following numbers, base the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsible in total and the more of the marker (800)
Division of Small Manufacturers, International and Consumer A Division of Sinall Manafactures, internet address

638-2041 of [phone] or w/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Naticy C. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Office of Docvices and Radiological Health

Enclosure

{6}------------------------------------------------

## Indications For Use Statement

| 510(k) Number (if known): | K052447 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SyneRad IMPACT 60 and SyneRad IMpact 72 and Analogic AMS1600 |
| Indications For Use: | The SyneRad Impact 60, SyneRad Impact 72 and Analogic AMS1600 are<br>Computed Tomography X-ray Systems intended to produce images of the<br>head and whole body by computer reconstruction of X-ray transmission<br>data at different angle and planes. This device may include signal analysis<br>and display equipment, patient, and equipment supports, components<br>and accessories. |

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

X

Over-The-Counter Use

(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leyson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number.

Analogic Corporation Amalogio Octporation.
SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS1600 CT Systems 510(k)

September 1, 2005 Page xii of xvii