AERODR SYSTEM

K102349 · Konica Minolta Medical & Graphic, Inc. · KPR · Nov 24, 2010 · Radiology

Device Facts

• Record ID: K102349
• Device Name: AERODR SYSTEM
• Applicant: Konica Minolta Medical & Graphic, Inc.
• Product Code: KPR · Radiology
• Decision Date: Nov 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The AeroDR SYSTEM is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Device Story

AeroDR SYSTEM is a digital radiography imaging system; captures X-ray images using a flat panel detector (FPD) with Cesium Iodide (CsI) scintillator; images transmitted to Console CS-7 via wired or wireless connection; system includes detector, operator console, interface units, access point, and battery charger; used in clinical settings to replace film/screen radiography; provides digital images for physician review to support diagnostic decision-making; benefits include transition to digital workflow and improved imaging efficiency.

Clinical Evidence

Bench testing only; compliance with IEC 60601-1 and IEC 60601-1-2 standards; risk management conducted per ISO 14971.

Technological Characteristics

Digital radiography system; Flat Panel Detector (FPD) with Cesium Iodide (CsI) scintillator; wired or wireless connectivity; includes operator console, interface units, and battery charger; Class II device.

Indications for Use

Indicated for generating radiographic images of human anatomy in general-purpose diagnostic procedures. Not for use in mammography, fluoroscopy, tomography, or angiography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Carestream DRX-1 System (K090318)
• KONICAMINOLTA, FlexDR C30 (K082347)

Submission Summary (Full Text)

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

# 510(k) Summary

as required by 807.92

## 1. Company Identification

NOV 2 4 2010

Konica Minolta Medical & Graphic, Inc. No.1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Establishment Registration Number: 3004485675

# 2. Submitter's Name and Address

Shigeyuki Kojima Manager Regulations and Standards Section, Quality Assurance Center No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan Telephone: [phone] Fax: [phone]

# 3. Date of Submission

August 11, 2010

4. Device Trade Name AeroDR SYSTEM

# 5. Common Name

Digital Radiography

## 6. Classification, Product Code

Class II , 21 CFR 892.1650, 90MQB and 21 CFR 892.2050, 90LLZ

## 7. Predicate Device

Carestream DRX-1 System, K090318 KONICAMINOLTA, FlexDR C30, K082347

#### 8. Device Description

The AeroDR SYSTEM is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Detector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice.

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

#### 9. Indications for Use

The AeroDR SYSTEM is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

## 10. Substantial Equivalence to Predicate Device

The predicate device and the AeroDR SYSTEM are the same digital imaging systems.

The Indications for Use of this new device and predicate devices are almost identical. The detector of the new device is FPD (Flat Panel Detector) with scintillator of Cesium lodide (Csl). The detector type of this new device and predicate device are the same. The principals of operation and technological characteristics of this new device and predicate devices are similar. The results of performance testing shows that there is no new safety and efficacy issue of The AeroDR SYSTEM introducing those already have identified with the predicate device.

#### 11. Safety Information

The AeroDR SYSTEM has been tested and shown to meet the requirements of IEC 60601-1 and IEC 60601-1-2.

The Risk Analysis for the AeroDR System was conducted on the basis of ISO14971, "Medical devices - Application of risk management to medical devices". As a result of risk control measures, the risk associated with all of the identified hazards was reduced to an acceptable level.

#### 12. Conclusion

Comprehensively, we judged that the AeroDR System has the same technological characteristics as the predicate devices. This 510(k) has demonstrated substantial equivalence as the predicate devices.

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The text is in a sans-serif font and is blue.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Konica Minolta Medical & Graphic, Inc. % Mr. Russell Munves Official Correspondent Storch, Amini, & Munves, P.C. 140 E. 45th Street, 25th Floor Two Grand Central Tower NEW YORK NY 10017

Re: K102349

Trade/Device Name: AeroDR SYSTEM Regulation Number: 21 CFR 872.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 8. 2010 Received: October 12, 2010

AUG - 9 2013

Dear Mr. Munves:

This letter corrects our substantially equivalent letter of November 24, 2010.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

NOV 2 4 2010

510(k) Number (if known)

: KIO2349

AeroDR SYSTEM Device Name

Indications for Use:

The AeroDR SYSTEM is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

The AeroDR SYSTEM is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

.

(Division Sign Off)
Division of Radiology Devices
Diagnostic Device Evaluation and S.

11

11/24/10

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)